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US report sets ground rules for artificial life

Synthetic biology needs oversight not over-regulation, commission finds.

By Meredith Wadman

A presidential commission has released a report that recommends White-House level oversight of U.S. research in synthetic biology-but it stops short of calling for new laws or changes to existing regulations that govern the nascent field, whether in university labs or do-it-yourselfers' garages.

It also claims to navigate a middle road between unbridled experimentation and a regulatory straightjacket that could stifle the most promising applications of synthetic biology, from malaria medicine to biofuels.

"The Commission endorses neither a moratorium on synthetic biology until all risks are identified and mitigated, nor unfettered freedom for scientific exploration," writes the 13-member Presidential Commission for the Study of Bioethical Issues, in its report released on December 16.

Rather, the commission writes, the field can proceed responsibly by embracing "an ongoing process of prudent vigilance that carefully monitors, identifies, and mitigates potential and realized harms over time."

Commission chair Amy Gutmann told Nature that the commission is not suggesting that a new White House "czar" position be created, but rather that existing structures in the Executive Office of the President-perhaps the Office of Science and Technology Policy, or top science adviser John Holdren-step in to oversee what is at present a fractured enterprise. "What the agencies could not assure us is that they have a coordindated effort on oversight," says Gutmann.

The first recommendation in the 188-page report is that the new White House body compile an exhaustive evaluation of current U.S. government funding for synthetic biology and make it public within 18 months.

Suicide genes

The report was commissioned in May, on the same day that J. Craig Venter and colleagues published the first synthetic bacterial genome. Responding to an avalanche of media attention, President Barack Obama asked his bioethics commission to delve into synthetic biology and make policy recommendations. The commission's research included three public meetings and testimony from ethicists, scientists, policy experts, religious thinkers and others.

Its 18 recommendations, based on five ethical principles defined by the commissioners, include mandatory ethics training for engineers working in the area-as biologists are now required to have.

It also asks the White House coordinating body to identify gaps in the risk assessment practices required before synthetic organisms are released, and says that synthetic microbes should be engineered to include "suicide genes" or laboratory-dependent nutritional requirements that would limit their lifespans in the event of inadvertent release.

Notably, it does not call for separate oversight of do-it-yourself synthetic biologists, stating that "presently there appears to be no serious risk of completely novel organisms being constructed in non-institutional settings including in the [do-it-yourself] community." Accordingly, "the Commission sees no need to imposed unique limits on this group."

Another recommendation tries to anticipate future media reactions to new, eye-catching achievements in the field, with the establishment of an independent organization-Gutmann suggests the moniker "biofactcheck.org"-that would poke holes in sensational or overstated claims.

The report won praise from some quarters, including the do-it-yourself community.

"The commission is being very forward-thinking by including considerations about amateur and non-institutional practitioners in the report," says Jason Bobe, co-founder of DIYbio.org, and organisation whose website says it is "dedicated to making biology an accessible pursuit for citzen scientists, amateur biologists and biological engineers who value openness and safety."

I think they tried to put DIYbio in perspective and were able to get beyond much of the hype," Bobe adds.

Future risks

But critics pounced on the report, saying it does not go far enough in anticipating and forestalling the potential risks of synthetic biology, including its use for producing bioweapons or the inadvertent escape of engineered microbes into the environment.

"It is very thin gruel," says Richard Ebright, a molecular biologist at Rutgers University in New Brunswick, New Jersey. Ebright argued that the combination of "intellectual freedom" and a corollary "regulatory parsimony" as one of the comission's five guiding ethical principles "resulted in a Commission report that suggests no substantive oversight and that is fundamentally empty."

Ebright would have liked the commission to require, for instance, mandatory local-level review of synthetic biology activities, along the lines of the IRB system used for human-subjects research. He also wanted mandatory national-level reviews of the subset of research of highest concern, such as the production of pathogens and toxins.

Others praised the report's call for open-ended watchfulness of the field going forward. "The overriding message of the report is that review of synthetic biology needs to be an ongoing affair, not a one-off thing. I think that's right," says Greg Kaebnick, a research scholar at the Hastings Center in Garrison, New York, which is conducting a two-year ethical review of synthetic biology.

Still, Kaebnick isconcerned by the report's numerous references to the futuristic nature of synthetic biology, and its relaxed attitude about the potential for more immediate dangers.

"I don't think the applications are that far off," says Kaebnick. "And the possiblity that things are in the future should not be offered as a reason to be confident about the risks."

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