UPDATED: Synthetic Biology Doesn't Require New Rules, Biothics Panel Says

16 December 2010 (All day)

President Barack Obama's bioethics commission today released its final report on the risks and benefits of the young field of synthetic biology. Its conclusion: no new regulations are needed, but federal officials should be vigilant in case bigger risks arise in the future.

Obama called for the study in May after a team led by biologist J. Craig Venter reported that it had inserted a synthetic genome into a self-replicating cell. After three meetings, the 13-member commission's central finding is that synthetic biology offers promise for producing biofuels and new medicines but doesn't yet pose serious risks to the environment or health. "The upside benefits of this technology and our commitment as a country to intellectual freedom suggest no moratoriums. ... No new agencies or laws are called for," says commission co-chair Amy Gutmann, president of the University of Pennsylvania.

Instead, the panel's 18 recommendations focus on dialogue and keeping an eye on the field. Within 18 months, a White House-level coordinating committee should publish reviews looking at funding, licensing policies, gaps in risk assessment, ethics education, and oversight rules for researchers. In addition, a private organization should create a fact-checking Web site that would correct exaggerations in the media about synthetic biology--such as claims that Venter created life. Venter's feat was "extraordinary in many ways, but "does not amount to creating life as either a scientific or moral matter," the report concludes.

Some experts are worried not so much about academic and company synthetic biologists but about amateurs tinkering in their garages. Harvard University's George Church told the bioethics panel that these "do-it-yourselfers" should be licensed and surveilled. But the panel concluded that the amateurs are nowhere close to synthesizing a self-replicating organism. "We're not there yet and we may never get there," Gutmann says.

But if synthetic biology takes off, new rules may be needed. If ongoing risk reviews by federal officials "identify significant unmanaged security or safety concerns, the government should consider making compliance with certain oversight or reporting measures mandatory for all researchers ... regardless of funding sources," the report says. The government may also need to review U.S. rules limiting information and materials sent to other countries. But any changes in these so-called export controls "should not unduly restrain" exchanges among international scientists, the report says.

The recommendations are essentially the same ones in a draft report that the commission discussed last month. Since then, the panel has tweaked some wording, added the 18-month timeline for reviews, and called for sharing the results with the public, Gutmann says.

The commission now expects to tackle two new projects. Beginning with its next meeting in February, the panel will review the ethics of genetic and neurological testing.

At Obama's request, the panel is also following up on the recent revelation that in the mid-1940s, a U.S. federal researcher deliberately infected patients in Guatemala with syphilis. The commission is forming a fact-finding team to investigate the unethical experiments, and it will ask an international task force to review whether U.S. rules for clinical trials in other countries are properly protecting human subjects today, Gutmann says.

UPDATE, 1:10 p.m.:

Some activists have criticized the report, saying more stringent controls on synthetic biology are needed. In a letter sent today to the commission, 58 environmental, religious, and other groups say the report is flawed because it didn't properly evaluate the environmental risks of releasing synthetic organisms, relies too much on "suicide genes" to prevent synthetic life forms from replicating if they do escape, and depends on industry to regulate itself. The groups—which include Friends of the Earth, ETC Group, and the International Center for Technology Assessment—call for a moratorium on the commercial use and release of synthetic organisms until the risks are better understood.

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