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House Committee Hears from Venter, Others on Synthetic Biology

By Matt Jones

NEW YORK (GenomeWeb News) – A week after a major milestone was achieved in synthetic biology, J. Craig Venter and other noted scientists in the field appeared on Capitol Hill yesterday morning to explain to lawmakers what synthetic biology is, where it may be leading, how it is overseen, and why they see it as more valuable than dangerous to humanity.

Researchers from the J. Craig Venter Institute reported last week that they had succeeded in booting up a microbe with a synthetic genome and watched it replicate a billion times. In the wake of the announcement, President Barack Obama called on his bioethics panel to look into the potential issues that may surround such technology, and the House of Representatives called a hearing.

On Thursday morning, Venter told the House Committee on Energy and Commerce that synthetic biology may be able to help us "wean ourselves off of oil" through the development of new biofuels. And Jay Keasling of the Lawrence Berkeley National Laboratory explained how this breakthrough could be employed to speed up the creation of next year's flu vaccine.

Committee Chairman Henry Waxman (D-Calif.) agreed with both points, saying that synthetic biology "has the potential to reduce our dependence on oil and address climate change," and that it "could lead to oil-eating microbes, which could be extremely useful right now," referring to a growing oil spill in the Gulf of Mexico.

Waxman also agreed with Anthony Fauci, director of the National Institute of Allergies and Infectious Disease, who explained to the lawmakers that this breakthrough is not a exactly a step into the unknown, but that it is a milestone in a continuum of biology that has been developing for 30 years.

A number of the House members said that they weren't familiar with the science behind synthetic genomics, and much of the hearing entailed broad descriptions of what the technology is and what it may mean.

Venter said that JCVI had briefed both the White House and Congress before the announcement was made about the development of this single-celled bacterial microbe.

"What it is not, it is not life from scratch," he said. "It is the first cell to have its parent be a computer," he explained, adding that it was "a real merging of the digital world and the biological world."

Waxman said that there is a "need to separate splashy headlines and science fiction scenarios from what researchers are doing.

"People who are worried about human beings being created should relax," he added.

Ethics and Dissent

The hearing included no strong critics or dissenting views on synthetic biology among the panel or the representatives.

One speaker, Gregory Kaebnick, sketched the bioethical boundaries of synthetic life, and three groups submitted written testimony for the record, but were not present.

Kaebnick, a research scholar at the Hastings Foundation who is working on a two-year project reviewing the ethics of synthetic biology, in his testimony outlined two general sets of concerns that the field has raised.

One set of 'intrinsic concerns' "has to do with whether the creation of synthetic organisms is a good or a bad thing in and of itself, aside from the consequences," he said, pointing to cloning as a similar example, which many people "just felt that it was wrong to do, regardless of benefits."

These issues involve spiritual or metaphysical attitudes, and bring up issues about the rightness of "playing God," as Kaebnick put it.

They also involve the worry that synthetic biology will undermine significant moral concepts, such as the fear that by creating life it will lose "the specialness we have always found in it," he explained.

"Synthetic biology need not change our understanding of the value of life, however," he said, explaining that the "natural" creation method of living things is not the only reason to believe that life is special.

Kaebnick also described "consequential concerns" about biosafety and about the deliberate misuse of synthetic biology. He said that these technologies should be controlled and contained, but added that misuse of synthetic biology may not be much different from misuse of current biological agents, such as the SARS virus and the 1918 flu virus, both of which have been produced in labs.

Aside from metaphysics and biosafety, synthetic biology critics often focus their concerns on the environment.

Jim Thomas, a research program manager with ETC Group, an environmental advocacy organization that has been critical of synthetic biology, told GenomeWeb Daily News in an e-mail that without dissenting voices on the panel the hearing was "a waste of valuable congressional time and resources," and that it was a two-hour advertisement for Venter-owned Synthetic Genomics and Amyris Biotechnologies.

"We were particularly disappointed that the committee hearing this morning did not see fit to invite critics of the field or to substantially address the risks and downsides of proposed applications but rather to uncritically cheer industrial hype in this field," Thomas said.

ETC submitted joint testimony to the committee along with Friends of the Earth and the International Center for Technology Assessment. These groups have together called for both the Environmental Protection Agency and the Food and Drug Administration to step in to regulate this field.

Questions on Oversight

Several committee members asked what the role of government should be in overseeing synthetic biology.

During questioning, NIAID's Fauci answered several committee questions about how synthetic biology is being, or will be, regulated. Currently, he explained, there are guidelines for entities that receive federal funding, which can be withheld, but none for those that do not use government money. For private industry, there are no guidelines and no enforcement over synthetic genomics, he said, but there is a "culture of responsibility."

The Recombinant DNA Advisory Committee plans to put out guidelines in June covering synthetic biology, Fauci explained.

In addition, three central US efforts have been undertaken so far to address the safety, security, and ethics of synthetic biology.

Most recently, the National Science Advisory Board for Biosecurity released a draft report in April on synthetic biology that advanced four main areas of recommendations. These recommendations cover institutional review for biosecurity risks, oversight of dual use research beyond the life sciences and academia, outreach and education strategies, and government endeavors for reviewing and watching new technological advances.

Late in 2009, the Department of Health and Human Services issued a guidance for synthetic genetics firms called "Screening Frameworks Guidance for Synthetic Double-Stranded DNA Providers."

This guidance focused on three major areas, including screening potential customers, screening sequences, and follow-up practices to be used if any 'red flags' are raised, and it made a number of specific proposals about practices for gene synthesis companies.

These recommendations are very similar to those developed by an industry group, the International Gene Synthesis Consortium, which was started as an effort to harmonize and implement the best practices of screening genes and customers.

In addition, the Europe-based International Association of Synthetic Biology announced in November that it had finalized its code of conduct for gene synthesis, covering ethics, biosafety, and biosecurity aspects of gene synthesis.

Fauci tried to assuage the concerns of some representatives who asked about the lack of oversight, and about how synthetic biology tools can be kept out of the hands of "bad guys."

"It adds much more to what can be done in a positive sense than it pushes the envelope of what you can do in a bad sense," said Fauci. "There are already enough things existing out there that if people with nefarious motives want to do it they can do it. They don't need synthetic biology."

Looking forward, Congress should not "overregulate something that needs care and responsibility and integrity and work with us in making sure we lay the foundation" for future research efforts, Fauci said.