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Congress Considers Synthetic Biology Risks, Benefits

A week after J. Craig Venter announced success in synthesizing a genome and using it to control a self-replicating cell, he was at the microphone again, this time testifying in front of the U.S. House Committee on Energy and Commerce. Along with two other synthetic biology experts, a bioethicist, and Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, Venter navigated a generally supportive round of questions concerning the potential benefits and risks of synthetic biology. And Fauci said that the government is moving quickly to bring synthetic biology under review by two existing panels that have done a good job of monitoring cutting-edge research in the past.

Fauci stressed the historical record. Decades of work on the genetic code and on methods of manipulating it, he said, enabled Venter and his colleagues at the J. Craig Venter Institute in Rockville, Maryland, and San Diego, California, to create a genome from scratch and use it to transform a bacterial cell. In the 1970s, prompted by the invention of recombinant DNA technology, the scientific community took steps to police itself. As a result, the National Institutes of Health (NIH) established the Recombinant DNA Advisory Committee, which oversees genetic engineering. And in the mid-1980s, the U.S. government decided the products of genetic engineering could be handled without an additional regulatory agency. In 2003, responding to concerns about biological research that could be used for civil or military purposes, NIH set up the National Science Advisory Board for Biosecurity to deal with such dual-use technology.

Although these two boards have not had jurisdiction over synthetic biology, they soon will, Fauci told the committee. NIH is currently reviewing public comments gathered last fall on guidelines for synthetic biology. He expects the new rules to be out in June. Those rules will include a voluntary program for companies that make DNA to scan orders for any sequences that could belong to small pox or other select agents that could be used by bioterrorists. He did not think additional regulations would be any more effective at deterring "nefarious" activity.

"The guidelines coming out are a great step" toward encouraging responsible behavior in synthetic biology, Venter said. He also stressed that researchers have been putting genes in and out of organisms with no safety problems for almost 40 years and that he and others are able to build new organisms that can't survive outside a special environment and thus would not be a threat in nature.

Gregory Kaebnick, a bioethicist at the Hastings Center in Washington, D.C., also testified. He is midway through a 2-year project looking at the ethical implications of synthetic biology. He called for further analysis of whether the current and upcoming regulations would be sufficient. "We should guard against overconfidence that we understand the risks," he told the committee.

Written testimony accepted into the record from a coalition of three watchdog groups was even more cautionary. The ETC Group, the International Center for Technology Assessment, and Friends of the Earth asked Congress to prohibit the release of synthetic organisms into the environment and their use in commercial settings. "The time has come for governments to fully regulate all synthetic biology and products," they wrote.

*Correction: Venter did not derive a self-replicating synthetic cell, as this article previously stated, but a synthetic genome which was used to control a self-replicating cell.