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Report Card on Government's Synthetic Bio Initiatives Shows Mixed Results

By Matt Jones

NEW YORK (GenomeWeb News) – The Obama Administration has started implementing several policy recommendations aimed at creating a vigilant and secure oversight for synthetic biology, as they were laid out in an administration report from two years ago, but it has not yet moved on around half of those proposals, according to an external review by the Synthetic Biology Project.

In response to a late 2009 report from the Presidential Commission for the Study of Bioethics, the White House has already taken some steps to fund synbio research, pursue data sharing measures, enhance oversight controls, and conduct some security assessments, according to the Synthetic Biology Project, an initiative of the Woodrow Wilson International Center for Scholars that is charged with keeping track of federal and non-federal efforts to govern synbio research.

However, the administration has yet to pursue several other recommendations, such as conducting a review of and disclosing all federal research funding in synthetic biology, developing a clear approach to synbio research across the government, coordinating internationally, conducting certain risk evaluations, and studying concerns about the release of synthetic organisms into the environment.

"The commission's report was a landmark document and lays out a framework with broad applicability to many emerging technologies, but, like many reports of this type, no mechanisms were put in place to track progress," David Rejeski, director of the Synthetic Biology Project, said in a statement. "Our goal is ensure that this report — and others like it — can drive change."

"Throughout the commission's deliberations and in the report, the members emphasized the need for transparency, dialogue, and accountability around synthetic biology," added Valerie Bonham, executive director of the Commission.

The Bioethics Commission's report proposed 18 total recommendations for how the government could provide oversight and address safety, security, and ethical concerns about synbio without hampering innovations in a field that offers potential in several areas, such as biofuel development, bioremediation, food production, and others.

President Barack Obama tasked the commission with producing the report on the same day that the J. Craig Venter Institute announced that it had created a synthetic genome and got it to 'boot up' and begin replicating after it was inserted into a pre-existing microbe.

Rejeski told GenomeWeb Daily News yesterday that during any given week half a dozen new government reports like that of the Bioethics Commission are released, and that they can "disappear into the furnace of the bureaucracy" and it is difficult to follow up on them.

He also said that election years, such as this one, are often "a black hole into which advisory reports disappear," and that it can be difficult to ensure that the reports have traction, particularly if there is a change in the administration.

"Often these kinds of reports are done by non-partisan groups and they should have traction, regardless of whether the Democrats or the Republicans are in office," Rejeski told GWDN.

"The report is pretty extensive, and went far beyond just dealing with ethics issues," Rejeski explained. "They talked about public engagement, ethics education, risk assessment, keeping tabs on federal funding. ... It was an interesting attempt to put out a framework that could be applied to lots of emerging technologies, and one of the important things was that they talked about the need to constantly update your understanding of the risks and whether the oversight systems work."

The Bioethics Commission "steered a middle path between regulation and a pure laissez-faire approach. The way it was written, the report's success depends on the implementation of a process just to monitor the developments of the science, the risks, and the ethical issues. But the commission had no real power to set up that mechanism," he said.

"It looks like the government has done some follow-up on about half of the recommendations, and if we throw in the non-federal activities there has probably been activity on about 70 or 80 percent of it," added Rejeski. "I can't tell you whether that is massive amounts of progress or not, but there is certainly activity there, so I think that is a good sign."

According to the Synthetic Biology Scorecard, the Obama Administration has not undertaken a coordinated evaluation of current public funding for synbio or the ethical and social issues raised by this new field — even though the commission proposed that such a review should be completed within 18 months of the report and that the results should be made public.

"The oversight system is spread across multiple agencies, and coordination really becomes a key issue, so it is important that we know where the funding is and what is being done," Rejeski said, explaining that such a review would serve as a base map for oversight. "My hope is that somebody is putting that together somewhere."

However, the administration has been funding research for synbio projects through the National Institutes of Health, the Department of Energy, and other departments, as the report advised, according to the Synthetic Biology Project.

Since 2006, for example, NIH has provided $108 million in grants, while the National Science Foundation has spent around $72 million and created the Synthetic Biology Engineering Research Center, and the Defense Advanced Research Projects Agency dedicated $30 million for a program called Living Foundries, which seeks to apply an engineering framework to biology. In addition, the Department of Agriculture has awarded at least $2.3 million in grants for synthetic biology-related research, and the Department of Energy's Joint BioEnergy Institute has used synbio in bioenergy and biofuel research projects.

"The funding picture is one that is better than stable and is likely to increase, even though the budget itself is under attack," Rejeski said.

The administration has acted in part on the commission's recommendation that it determine whether current research licensing and sharing practices are sufficient to ensure that synbio research results can be used to promote innovation.

The DOE Office of Science's Office of Biological and Environmental Research Genomic Science program has begun development of the DOE Systems Knowledgebase, which will contain genetic blueprints and functional biological information that will be available for sharing data. DOE's Joint Genome Institute also has formed a synthetic biology group to focus on data mining combined with gene synthesis and functional analyses for large-scale characterization of genes and regulatory sequences.

However, no such sharing-related activities were currently identified by the Synthetic Biology Project at NIH, the White House, the National Academy of Sciences, or at the US Patent and Trademark Office.

The Bioethics Commission also recommended that some entity should be tasked with creating a coordinated review of developments in synbio, ensuring that regulatory requirements are consistent, and informing the public about what it discovers through its reviews , although it saw no need to create additional oversight agencies specifically to cover synbio activities. The Synthetic Biology Project said that the administration has not yet started such a review process.

The report also urged the government to address concerns about the potential harms that could come if new synthetic organisms are inadvertently released into the environment and to assess the risks of such a release. Specifically, the commission suggested that the Executive Office of the President should direct an ongoing review of the ability of synthetic organisms to multiply in the natural environment and to identify potential control or containment mechanisms, such as "suicide genes" or other self-destruction triggers. According to the Synthetic Biology Project, the Obama Administration also has not yet launched such a review.

The administration has not entirely neglected concerns about synthetic biology security and safety, however. For example, the Federal Bureau of Investigation has listed synthetic biology as one aspect of a review it is conducting under its Weapon of Mass Destruction Directorate, and it has partnered with the synbio community to articulate relevant safety and security concerns. DARPA also has created an expert panel to address ethical, legal, social, and biosecurity and safety concerns as part of its Living Foundries program.

Because the government has taken steps to address bioterrorism in recent years, Rejeski said that it "has done a relatively good job" on the synbio security issues identified in the report. He added that the government's performance on safety issues is more difficult to assess because it is spread across a number of agencies.

Rejeski also noted that because so many of the commission's recommendations have to do with coordination, it is likely that there have been meetings happening on some of these proposals that are not going to show up on anyone's radar just yet. Such internal meetings and activities "would not necessarily pop out as a product, but they are important," he said.

The Synthetic Biology Report plans to update its synbio scorecard around every six months.

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