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Oversight of Synthetic Biology research/products, Federal agencies

From Nature published online, 7/7/10 (1) an interview with Amy Gutmann, Chair of The Presidential Commission for the Study of Bioethical Issues (US)

in which [she]discusses the challenges of bringing synthetic biology to the public arena….[within 6 months]Our challenge is to consider all reasonable perspectives on synthetic biology and allow for an exchange of ideas that leads to as much common ground as possible..… Our power is in the reasonableness of our recommendations. Then we have to leave it to those whom we advise. Our report will be out there in the public domain and that has value in itself.
Their first meeting was held July 8-9 2010, 7 sessions can be watched via archived video on their website. From the Federal Oversight session (2), recommendations included that the Federal gov’t conduct a full review of the current regulatory system to assess risks in this emerging new field. Funding should be provided for research on how to assess risks/benefits, especially so that Federal agencies will have an independent basis on which to make their future decisions. Existing law regulates biotech products (rather than the biotech process itself) under the auspices of various federal agencies, so existing regulations should also apply to first generation synthetic biological products. As field develops, more complex products are developed, more review and assessment likely will be needed . Many synthetic bio research activity issues are similar to those raised during national/local debates on biosafety on regulating recombinant DNA research and activity in 1970s-80s. ( Michael Rodemeyer, J.D. presentation)
(1)http://www.nature.com/news/2010/100707/full/news.2010.340.html Interview by Meredith Wadman,Published online 7 July 2010 | Nature | doi:10.1038/news.2010.340 . Future Bioethics Commission meetings on synthetic biology will be held University of Pennsylvania on September 13-14 and at Emory University in November. The public is invited.
http://www.bioethics.gov/documents/Letter-from-President-Obama-05.20.10.pdf For the first time, all of the natural genetic material in a bacterial cell has been replaced with a synthetic set of genes. As its first order of business the bioethics Commission will study the implications of this scientific milestone in the emerging field of cellular and genetic research known as synthetic biology , as well as other advances that may lie ahead in this field of research.(e.g accelerating vaccine development).

-A brief review of the last 40 years of biotech development. Major categories of risk posed by biotech research include: biosafety (adverse affects on lab workers/general public), biosecurity (accidental exposure to a pathogen/toxin, deliberate misuse of technology to cause harm to humans, plants, animals, environment), safety of research subjects (clinical admin of biotech products could adversely affect individual research subjects) and societal norms (controversial uses/consequences of technology, e.g. germline interventions, enhancements, genetically modified orgs.); (Amy Patterson, M.D. presentation/slides)

-Pointed out that screening/notification framework guidance for synthetic double stranded DNA providers is in place under FBI biosecurity; see UNICRI for int’l aspects of biosecurity, the role of the FBI in mitigating the potential risks includes outreach, partnering, effective policy making with industry/academia. ( Edward H. You presentation/slides)

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