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Synthetic biology is an emerging technical field that aims to make biology easier to engineer; the field has applications in strategically important sectors for the US economy. While the United States currently leads in synthetic biology R&D, other nations are heavily investing in order to boost their economies, which will inevitably diminish the US leadership position. This outcome is not entirely negative—additional investments will expand markets—but it is critical that the US government take steps to remain competitive: There are applications from which the US population and economy may benefit; there are specific applications with importance for national defense; and US technical leadership will ensure that US experts have a leading role in synthetic biology governance, regulation, and oversight. Measures to increase competitiveness in S&T generally are broadly applicable for synthetic biology and should be pursued. However, the US government will also need to take action on fundamental issues that will affect the field's development, such as countering anti-GMO (genetically modified organism) sentiments and anti-GMO legislation. The United States should maintain its regulatory approach so that it is the product that is regulated, not the method used to create a product. At the same time, the United States needs to ensure that the regulatory framework is updated so that synthetic biology products do not fall into regulatory gaps. Finally, the United States needs to pay close attention to how synthetic biology applications may be governed internationally, such as through the Nagoya Protocol of the Convention on Biological Diversity, so that beneficial applications may be realized.

Full-text available at SSRN. See link in this record. ; In his Nobel Prize acceptance speech more than half a century ago, Edward L. Tatum suggested an ambitious new goal for biology: "not only to avoid structural and metabolic errors in the developing organism, but also to produce better organisms." Synthetic biology aims to effect such a paradigm shift in the biological sciences by marrying approaches from engineering and computer science to an expanding array of standardized biological parts and sophisticated biological methods. By importing engineering principles, such as standardization, decoupling, and abstraction, into the biological sciences, synthetic biology may transform biology into a field in which it is routine to design and construct genes, gene combinations, genomes, proteins, metabolic pathways, cells, viruses, and whole organisms rapidly, inexpensively, and easily. Already, a number of institutions have helped synthetic biology achieve considerable success, both in terms of science and public awareness. The BioBricks Foundation (BBF) and the Registry of Standard Biological Parts have successfully built a collection of thousands of standard DNA parts (BioBricks), which can be combined in a manner analogous to Lego® bricks, or even modified into new BioBricks, and the International Genetically Modified Machine (iGEM) competition has attracted participation from thousands of contestants and hundreds of teams from dozens of countries. While the ethos of openness that pervades synthetic biology promises a democratization of biology, significant challenges to its openness still exist. The proprietary restrictions imposed by "closed" intellectual property - chiefly patents - create legal risk and uncertainty. Ironically, synthetic DNA sequences are likely more easily patentable and copyrightable than are DNA sequences derived from natural sources, thus creating the possibility that synthetic biology may increase, rather than decrease, the potential for intellectual property restrictions. Furthermore, ...

As resistance to synthetic biology slowly coalesces, governments and scientists need to be proactive to avoid a repetition of the near moratorium on genetically modified crops in Europe.

Biocentrism maintains that all living creatures have moral standing, but need not claim that all have equal moral significance. This moral standing extends to organisms generated through human interventions, whether by conventional breeding, genetic engineering, or synthetic biology. Our responsibilities with regard to future generations are relevant to non-human species as well as future human generations. Likewise, the Precautionary Principle raises objections to the generation of serious or irreversible harm or changes to the quality of human or non-human life, and needs to be applied when the introduction of synthetic biotechnology is envisaged. Consideration of this Principle supplements the problems raised for synthetic biology from a biocentric perspective. The bearing of biocentrism on religions is also considered, together with contrasting views about science, religion and the creation of life.

"Scientific advances over the past several decades have accelerated the ability to engineer existing organisms and to potentially create novel ones not found in nature. Synthetic biology, which collectively refers to concepts, approaches, and tools that enable the modification or creation of biological organisms, is being pursued overwhelmingly for beneficial purposes ranging from reducing the burden of disease to improving agricultural yields to remediating pollution. Although the contributions synthetic biology can make in these and other areas hold great promise, it is also possible to imagine malicious uses that could threaten U.S. citizens and military personnel. Making informed decisions about how to address such concerns requires a realistic assessment of the capabilities that could be misused. To that end, the U.S. Department of Defense, working with other agencies involved in biodefense, asked the National Academies of Sciences, Engineering, and Medicine to develop a framework to guide an assessment of the security concerns related to advances in synthetic biology, to assess the levels of concern warranted for such advances, and to identify options that could help mitigate those concerns"--Summary.

International audience ; Synthetic biologists are extremely concerned with responsible research and innovation. This paper critically assesses their culture of responsibility. Their notion of responsibility has been so far focused on the identification of risks, and in their prudential attitude synthetic biologists consider that the major risks can be prevented with technological solutions. Therefore they are globally opposed to public interference or political regulations and tend to self-regulate by bringing a few social scientists or ethicists on board. This article emphasizes that ethics lies beyond prudence and requires a cultural evaluation of the modes of existence of the various microorganisms designed by synthetic biologists, independently of their potential applications.

International audience ; Synthetic biologists are extremely concerned with responsible research and innovation. This paper critically assesses their culture of responsibility. Their notion of responsibility has been so far focused on the identification of risks, and in their prudential attitude synthetic biologists consider that the major risks can be prevented with technological solutions. Therefore they are globally opposed to public interference or political regulations and tend to self-regulate by bringing a few social scientists or ethicists on board. This article emphasizes that ethics lies beyond prudence and requires a cultural evaluation of the modes of existence of the various microorganisms designed by synthetic biologists, independently of their potential applications.