U.Va. Bioethicist, a Member of Presidential Commission, Recommends 'Prudent Vigilance' in Synthetic Biology

December 16, 2010

December 16, 2010 — Spurred by the May 20 announcement by the J. Craig Venter Institute that it had inserted a laboratory-made genome into a bacterial cell, creating an organism not found in nature, the Presidential Commission for the Study of Bioethical Issues today released its first report, tackling the emerging field of synthetic biology.

The wide-ranging report identifies potential benefits of synthetic biology, including the development of vaccines and new drugs and the production of biofuels that could someday reduce the need for fossil fuels.

The report also acknowledges risks posed by the technology in the medium- and long-term, including the inadvertent release of a laboratory-created organism into nature and the potential adverse effects of such a release on ecosystems.

But the technology is currently at a rudimentary stage, years and perhaps decades away from "actually creating life in the laboratory," explained one of the 13 commission members, bioethics professor John D. Arras of the University of Virginia's College of Arts & Sciences. This gives regulators, ethicists and others time to identify any problems early on and craft solutions that can harness the technology for the public good.

Citing uncertainty about risks at this nascent stage, the report makes 18 recommendations, including coordinated federal oversight of the field, enhanced transparency, ongoing risk analysis, public engagement and stepped-up ethics education for researchers.

"We comprehensively reviewed the developing field of synthetic biology to understand both its potential rewards and risks," said Amy Gutmann, the commission's chair and president of the University of Pennsylvania. "We considered an array of approaches to regulation – from allowing unfettered freedom with minimal oversight to prohibiting 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."

Arras explained, "We are not dismissing risks, but highlighting them, and charging government to keep an eye on this, and to make sure there are no gaps in regulatory oversight. We are calling for perpetual, iterative review of this science."

Arras is the Porterfield Professor of Biomedical Ethics, a professor of philosophy and founding director of the undergraduate bioethics program, the first of its kind in the United States.

"How do you handle technologies that have tremendous potential for benefit as well as potential for tremendous harm?" he said. "It's a huge problem – made even bigger by the global nature of the technology. If we banned the technology in this country, it would still develop elsewhere. Often the best way to be in a position to respond to various threats is not to ban a technology, but to get good at it."

The commission concluded that while the technical challenges of synthetic biology remain daunting, the field is likely to become more decentralized as the relevant tools become increasingly available and affordable – a change that may pose novel challenges with regard to oversight.

"While the 'Do-It-Yourself' community has an important role to play in advancing synthetic biology, we recognize that technical challenges and costs are too high right now for a completely novel organism to be developed in a non-institutional setting," said James W. Wagner, the commission's vice chair and president of Emory University. "We strongly support an open dialogue between DIY groups and the government as we go forward so that scientists and government can discuss the research constraints necessary to protect public safety as the field continues to evolve."

Among the commission's 18 recommendations:

•    The Executive Office of the President, possibly through the Office of Science and Technology Policy, should coordinate federal agencies that oversee areas related to synthetic biology, including oversight, product licensing and funding.
•    Risk assessment activities across the government need to be coordinated and field release permitted only after reasonable risk assessment.
•    The Executive Office of the President should remain actively engaged with "do it yourself" groups to communicate and discuss applicable safety and security issues.
•    Recognizing that international coordination is essential for safety and security, the Department of State, with the Department of Health and Human Services and the Department of Homeland Security, should collaborate with governments around the world, as well as leading international organizations, such as the World Health Organization, to promote ongoing dialogue about emerging technologies like synthetic biology.
•    The National Institutes of Health, the Department of Energy and other federal agencies should evaluate research proposals through peer review in order to make sure that the most promising scientific research is conducted on the public's behalf.
•    Educational classes on the ethical dilemmas raised by synthetic biology should be a mandatory part of training for young researchers, engineers and others who work in this emerging field.
•    Forums should be established to improve the general public's understanding of this field, including the creation of a biology equivalent to FactCheck.org, in which a private group would track statements about the science and offer an independent view of the truth of such claims.

Gutmann noted that the issues considered are relevant well beyond government officials and emphasized the value of informed public conversation regarding scientific research.

"The public, journalists and policymakers need facts and reliable analyses to help them understand the benefits as well as the risks of new technologies," Gutmann said. "To aid public understanding of emerging scientific issues, the commission is recommending that an independent organization do for synthetic biology and biotechnology what factcheck.org does for politics – be an online resource to check the truthfulness of prominent claims and criticisms about new scientific discoveries and help spur informed discussion."

President Obama asked the commission to study the implications of synthetic biology following the Venter Institute's May 20 announcement.

To consider a range of possible actions the government could take to prevent problems that might occur in the future, the commission held three public hearings over the past five months in Washington, Philadelphia and Atlanta. The commission heard from more than 30 ethicists, scientists and others close to the issue, including Michael Rodemeyer, an adjunct faculty member in the U.Va. Engineering School's Department of Science, Technology and Society. Rodemeyer was the founding director of the Pew Initiative on Food and Biotechnology from 2000 to 2005.

Existing laws and regulations that cover biotechnology products are likely to be sufficient to deal with the first-generation products of synthetic biology, expected to be relatively simple and similar to the types of genetically engineered counterparts already regulated, said Rodemeyer, who also served as the assistant director for environment in the White House's Office of Science and Technology Policy under the Clinton administration, following 15 years on the staff of the House of Representatives Committee on Science.

While it's unlikely that novel risks will arise in the short-term, he said, "As the technology continues to develop and as organisms become more complex, more novel and more artificial, the challenge will be to be able to assess the risks of those organisms in advance. And that's especially a concern for organisms that will be intended for use in the environment."

About the Presidential Commission for the Study of Bioethical Issues

The commission is an advisory panel of the nation's leaders in medicine, science, ethics, religion, law and engineering. The commission advises the president on bioethical issues arising from advances in biomedicine and related areas of science and technology. The commission seeks to identify and promote policies and practices that ensure scientific research, health care delivery and technological innovation are conducted in a socially and ethically responsible manner.

Media Contact

H. Brevy Cannon

Media Relations Associate Office of University Communications