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Jul 17, 2012

Scorecard Chides Administration on Synthetic Bio Policy Follow-Up

  • President Barack Obama’s administration has not fully addressed any of the recommendations made by its Presidential Commission for the Study of Bioethical Issues a year and a half ago for improving the governance of synthetic biology research and development, a policy group asserted.

    The Synthetic Biology Project at the Woodrow Wilson International Center for Scholars acknowledged that the administration and several federal agencies have taken steps over the past four months to set into motion many of the recommendations, delivered by the commission in a December 2010 report.

    But in a “Scorecard” graphic posted Monday on its website, the Project asserted that all progress reported to date had been partial, with the federal government taking no action to implement four of the recommendations:

    • Undertake a coordinated evaluation of current public funding for synthetic biology activities.
    • Carry out “reasonable” risk assessments before field release of research organisms or commercial products involving synthetic biology technology.
    • Develop a process for considering moral objections to synthetic biology, particularly if fundamental changes occur in its applications or capabilities.
    • Consider developing guidance materials and voluntary recommendations to assist manufacturers, after evaluating current statutory mandates or regulatory requirements for risks and benefits.

    The Project cited several examples of ongoing efforts by Obama’s administration and federal agencies toward addressing 13 of the remaining 14 recommendations, including some efforts that predated the commission’s December 2010 report, New Directions: The Ethics of Synthetic Biology and Emerging Technologies. Recommendations were intended to ensure that the social and economic benefits of synthetic bio are realized while risks are minimized.

    Addressing the recommendation calling for peer-review and other mechanisms to ensure “the most promising” scientific research is carried out for the public, the Scorecard noted that Obama’s 2009 Strategy for American Innovation included $800 million in grants from his $814 billion stimulus measure or American Recovery and Reinvestment Act, and another $500 million in loan guarantees, for biofuel development “harnessing recent advances in synthetic biology.”

    However an updated version of the document from 2011 omitted mention of synthetic biology, the Project noted.

    Synthetic bio fared better with several agencies. Since 2006, for example, NIH has awarded about $108 million in grants for synthetic bio research, with NSF awarding another $72 million.

    Obama’s administration moved to address another recommendation—developing a coordinated approach to synthetic bio research—when the White House Office of Science & Technology convened a synthetic biology working group under the National Science and Technology Council's Subcommittee on Life Sciences.

    In April, Obama released a National Biotechnology Blueprint that cited synthetic biology as a key foundational technology to the future bioeconomy. And two years ago, the administration created an Emerging Technologies Interagency Policy Coordination Committee in part to examine the policy implications of synth bio.

    The policy coordination panel developed Principles for Regulation and Oversight of Emerging Technologies by agencies, as required by Executive Order 13563 issued Jan. 18, 2011, which the project said helped fulfill commission recommendations to create mandatory oversight controls and foster accountability by institutions without unduly limiting intellectual freedom. The panel also partially addresses the commission recommendation that the administration and others should identify mechanisms that ensure that synthetic biology risks are not unfairly or unnecessarily distributed, and should identify gaps in current risk assessment practices related to field release of synthetic organisms, with an eye to identifying differences in methods or strategies between agencies.

    Yet as the project noted, many efforts in that vein have been carried out privately, stretching back to a 2007 report by the J. Craig Venter Institute, MIT, and the Center for Strategic and International Studies on the safety and security concerns posed by synthetic biology.

    FBI’s Weapon of Mass Destruction Directorate listed a partnership with the synthetic biology community among recent accomplishments, while the defense department’s Defense Advanced Research Projects Agency (DARPA) created an expert panel for ethical, legal, and social issues. The commission called for periodically assessing security and safety risks of synthetic biology research activities in both institutional and noninstitutional settings.

    Several recommendations saw only minimal government follow-up:

    • NIH updated its guidelines in October to include synthetic DNA within the overall definition of recombinant DNA. The commission recommended developing reliable containment and control mechanisms for multiplication of synthetic organisms in the natural environment.
    • Other than a 2010 workshop by the energy department with the Wilson center and Alfred P. Sloan Foundation to explore “ethical, legal, or social issues,” a recommendation to “maintain an ongoing exchange regarding the views of religious, civil society, and other groups on synthetic biology” has mainly been carried out through private efforts such as Principles for the Oversight of Synthetic Biology, a March 2012 declaration published by Friends of the Earth and endorsed by more than 100 organizations.
    • The National Science Advisory Board for Biosecurity last year published Strategies to Educate Amateur Biologists and Scientists in Non-life Science Disciplines About Dual Use Research in the Life Sciences, the only Washington step toward the recommendation to promote overall scientific and ethical literacy, particularly as related to synthetic bio.

    In all, five of six recommendations calling for action within 18 months saw at least some administration follow-up, the project concluded.

    The project doesn’t track the commission’s Recommendation 15 because it requires no action of the administration. It urges individuals and groups discussing synthetic biology to “employ clear and accurate language” rather than what the commission dismissed as “sensation­alist buzzwords and phrases such as ‘creating life’ or ‘playing God’.”

    “Such words impede ongoing understanding of both the scientific and ethical issues at the core of public debates on these topics,” the commission contended.


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