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UPDATE: White House Synthetic Bio Commission Urges Enhanced Oversight

This article has been updated with comments from the vice chair of the commission and a bioethicist.

By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) – A White House-appointed commission today recommended that federal agencies should oversee some areas of synthetic biology, such as regulation, product licensing, and funding, in order to protect the public from potential risks while not shackling promising research efforts.

The report from the Presidential Commission for the Study of Bioethical Issues advises that the White House should coordinate federal agencies for those duties, should assess the potential risks the synthetic bio field poses, take steps to monitor do-it-yourself labs engineering organisms, and start other initiatives to monitor this emerging field.

US President Barack Obama charged the commission with looking into synthetic biology immediately after the J. Craig Venter Institute announced that it had created the world's first synthetic genome, inserted it into a microbe, and made it start replicating — spurring exaggerated headlines suggesting that JCVI had created synthetic life.

The commission held three public hearings and consulted with scientists, ethicists, and others to explore the benefits of synthetic bio, such as new vaccines, drugs, and biofuels, as well as the risks, including the inadvertent release of organisms into nature and similar hazards.

"We comprehensively reviewed the developing field of synthetic biology to understand both its rewards and risks," explained Amy Gutmann, the Commission Chair and President of the University of Pennsylvania, in a statement.

"We considered two very different approaches to regulation — one to allow unfettered freedom with minimal oversight and another to prohibit experiments until they can be ruled completely safe beyond a reasonable doubt. We chose a middle course to maximize public benefits while also safeguarding against risks," Gutmann added.

The commission's primary recommendations in "New Directions: The Ethics of Synthetic Biology and Emerging Technologies," center around ways to use government and private sector resources to oversee synthetic bio research and business without stifling innovation.

As James Wagner, vice chair of the commission and president of Emory University, told GenomeWeb Daily News on Wednesday, one of best tools to protect against potentially damaging accidents is to "ensure that the science keeps advancing."

However, because of both the newness of some of the science and the potential for harm, the commission called for some measures to be taken to monitor the field.

"Prudent vigilance suggests that federal oversight is needed and can be exercised in a way that is consistent with scientific progress,' Gutmann said.

"We felt that synthetic biology is blooming in a number of areas, and is being funded through a number of areas, and also it is being scrutinized and regulated in a number of places," Wagner told GWDN.

He said the commission decided that "rather than propose new regulatory schemes or new regulatory agencies, or that there be specific funding agencies [for synthetic bio], that the very first step would be to take an inventory of what is already ongoing and coordinate that more effectively and efficiently."

One central recommendation calls for the executive branch to undertake a coordinated evaluation of public funding for synthetic bio, including research on risk assessment and risk reduction, and to study the ethical and social issues raised by this field. The findings of that evaluation should be completed within 18 months and should be made public, the commission advised.

The National Institutes of Health, the Department of Energy, and other federal agencies also should continue evaluating synthetic bio-related research proposals through peer review and other processes to "ensure that the most promising scientific research is conducted on behalf of the public."

The report recommends that the executive branch also determine whether current research and licensing and sharing practices are sufficient to ensure that basic research results are available to promote innovation.

There is no current need to create any additional agencies or oversight bodies focused specifically on synthetic bio activities, the commission found, but "a mechanism or body should be identified" to provide an ongoing review of the field, to ensure that regulations are consistent, and that the public will be informed of those findings.

"There's an argument about whether synbio is a new breakout field … it has so much in common with genetic engineering that we imagined that so many of the important tools about how to best benefit society and protect society may already exist at a sufficient level to address this discipline in its infancy," Wagner said.

He added that the commission found that "there are a lot of very important and legitimate and vital oversight and funding directives and agencies already in place."

Because of this pre-existing regulatory tableau, the commission recommended that any regulatory processes related to synthetic bio should be evaluated and updated, as need, and the White House should convene an interagency process to look into risk-assessment activities and efforts to harmonize activities across the government.

Responding to the report in a statement this morning, J. Craig Venter said that the commission's report is "comprehensive, and that their recommendations are wise, warranted and restrained, which will help to ensure that this young field of research will flourish in positive manner."

Venter said that JCVI has been "focused on and concerned with the applications and advances in this research in tandem with the ethical and societal implications of our work" since it began experimenting with synthetic genomics, and he called the report "very positive for this field."

Biotechnology Industry Organization President Jim Greenwood said in a statement that he liked that the commission showed in the report that it "understands that synthetic biology is not something radically new, but is part of an ongoing evolution of biotech innovation that has safely and successfully produced public benefits for the past 20 years."

Because the technologies involved in synthetic bio have been developing for decades, Greenwood explained, the regulatory framework in biotech is "generally applicable and relevant for the products of synthetic biology.

"Voluntary regulatory guidelines have been established and industry is responsibly adhering to these guidelines," Greenwood added.

He added, however, that BIO's members would be willing to work with the government and other stakeholders to determine if some current voluntary guidelines should become mandatory.
"Additional regulation in specific areas can be carefully designed and established," he said.

Gregory Kaebnick, a research scholar at the Hastings Center, a research institute focused on bioethics, told GWDN today that private sector synthetic genetics have little to fear from this commission's report.

"It doesn't call for any kind of stepping away from the technology, or slowing down" of the field through regulation, Kaebnick said.

He wondered if the commission may be "calling for too much from the Executive Office of the President, which, after all, has a lot of other things on its plate," but said that the recommendations "strike a nice balance."

Kaebnick also said he found the report to be forward-looking.

"They recognized that review of synthetic biology is not a one-off affair: that the field is very rapidly changing and we don't' really know what's coming down the pike. Therefore, review has to be an ongoing process – watching it, anticipating new steps, new directions, and constantly reassessing the field," he explained.

Kaebnick also agreed with the commission's view that synthetic bio does not necessarily represent entirely new technologies, in spite of its ability to make headlines.

He pointed to the widespread use of the enzyme chymosin in hard cheeses, which is produced by genetically-modified bacteria, as one example of how synthetic bio-engineering has been employed "very quietly without any whisper of protests."

"I haven't heard anyone describe that particular organism as an instance of synthetic biology," he said.

"We welcome the Commission's recommendations. They propose sensible steps to encourage the responsible development of synthetic biology — a field of discovery that may help solve many problems that until now have seemed intractable," said Ralf Wagner, CEO and CSO of GENEART, among the founders of the International Gene Synthesis Consortium.

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