National Academies Press: OpenBook

Biodefense in the Age of Synthetic Biology (2018)

Chapter: Appendix F Study Methods

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Suggested Citation:"Appendix F Study Methods." National Academies of Sciences, Engineering, and Medicine. 2018. Biodefense in the Age of Synthetic Biology. Washington, DC: The National Academies Press. doi: 10.17226/24890.
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Suggested Citation:"Appendix F Study Methods." National Academies of Sciences, Engineering, and Medicine. 2018. Biodefense in the Age of Synthetic Biology. Washington, DC: The National Academies Press. doi: 10.17226/24890.
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Page 220
Suggested Citation:"Appendix F Study Methods." National Academies of Sciences, Engineering, and Medicine. 2018. Biodefense in the Age of Synthetic Biology. Washington, DC: The National Academies Press. doi: 10.17226/24890.
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Page 221
Suggested Citation:"Appendix F Study Methods." National Academies of Sciences, Engineering, and Medicine. 2018. Biodefense in the Age of Synthetic Biology. Washington, DC: The National Academies Press. doi: 10.17226/24890.
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Appendix F Study Methods COMMITTEE COMPOSITION The National Academies of Sciences, Engineering, and Medicine (the National Academies) appointed a committee of 13 experts to undertake the statement of task. Members provide the perspectives of academia, industry, government, and the nonprofit sector and have experience in synthetic biology, biosafety, microbiology, public health, bioinformatics, and risk assessment. Appendix D provides the biographical information for each committee member. MEETINGS AND INFORMATION GATHERING The committee deliberated from approximately January 2017 to February 2018. To respond to its charge, the committee gathered information and data relevant to its statement of task by conducting a review of available literature and other publicly available resources, inviting experts to share perspectives at public meetings, and soliciting public comments online and in person. The study was conducted in two phases. In Phase 1 of the study, the committee met several times in person and held webinars to gather information, understand the needs of the relevant federal agencies, and develop a tool for assessing the biodefense threat to guide the study’s second phase. During this phase, the committee defined the type of framework that would guide the assessment of concerns, identified major categories of relevant technologies and applications to assess, and discussed the factors to include in the assessment. In Phase 2, the committee met additional times and incorporated further input and data-gathering to refine the framework for assessing potential biodefense concerns. It applied this framework to analyze specific potential applications of synthetic biology and to identify current areas of concern created by synthetic biology. Over the course of the study, the committee held seven meetings in Washington, DC, and Irvine, California. Three of these seven meetings included an open information-gathering component. During these open meetings, the committee heard from a variety of academic and private-sector researchers, as well as federal government officials. These meetings focused on understanding the current and near-term research being conducted in the field of synthetic biology and relevant adjacent scientific fields, understanding the current operations and research occurring within the federal government, understanding the existing concerns of biodefense and biosecurity professionals, and enlisting the assistance of these academics and professionals to scan the horizon for potential future technology developments and emerging threats. The remaining four meetings were closed to the public and served as time for the committee members to deliberate and write their report. The three open meetings are detailed below. 218 PREPUBLICATION COPY: UNCORRECTED PROOFS

219 Biodefense in the Age of Synthetic Biology The first open meeting, held January 26–27, 2017, in Washington, DC, provided an opportunity for the committee to discuss the study charge with the sponsor, as well as relevant needs of non-sponsor government agencies. The committee also heard a general overview of synthetic biology, a report out on previous work that had been performed by the President’s Council of Advisors on Science and Technology and the JASONs relevant to this study, and a presentation from another group that had done risk analyses and framework development for the U.S. Department of Defense. The second meeting, held May 24–25, 2017, in Washington, DC, included speakers who reviewed relevant aspects and current research on DNA synthesis, assembly, and engineering; on virus engineering, transmissibility, and zoonosis; on the idea of “ease of use” and its applicability to potential risks arising from synthetic biology; and an exercise in horizon-scanning and looking to the future. The third meeting, held July 6–7, 2017, in Washington, DC, included speakers who presented on the current state of public health and military preparedness; on efficacy of design in synthetic biology, focusing on what is truly possible and what is still not possible; on the current state of human modulation; and on emerging technologies that might assist or abet overcoming existing technical barriers. The committee also held two public webinars. The first was held March 10, 2017, and included talks on how to approach creating a strategic framework to assess the potential risks of synthetic biology, as well as a review of some of the objectives and accomplishments of the biological weapons program of the Soviet Union. The second webinar was held March 23, 2017, and included a talk on a review of prior attempts at frameworks and strategies to assess potential risks of synthetic biology. Both of these webinars were advertised and open to the public, although the committee did not accept questions or comments from the public during these webinars as their primary purpose was to serve as information-gathering activities for the committee. PUBLIC COMMUNICATION The committee’s two largest data-gathering meetings, in May and July 2017, provided opportunities to interact with additional stakeholders, including interested researchers and other parties. These participants contributed their views during open discussions following speaker presentations. The committee also worked to make its activities as transparent and accessible as possible for those who may not have been able to attend in person. The study website, http://nas- sites.org/dels/studies/strategies-for-identifying-and-addressing-vulnerabilities-posed-by- synthetic-biology, was updated regularly to reflect the recent and planned activities of the committee. Study outreach included a study-specific email address for submitting comments and questions to the committee. Following the release of the study’s interim report in August 2017, the study committee requested input from the public via an online survey. The survey was distributed widely through existing National Academies mailing lists, through the social and professional networks of the study committee, and through the Engineering Biology Research Consortium’s mailing list. Public comments were collected, and the committee members reviewed all comments and incorporated relevant and applicable commentary into their work on the final report. PREPUBLICATION COPY: UNCORRECTED PROOFS

Appendix F 220 Any information provided to the committee from outside sources or through the online comment tool is available by request through the National Academies’ Public Access Records Office. Invited Speakers The following individuals were invited speakers at meetings and data-gathering sessions of the committee: Chris Anderson Polina Anikeeva University of California, Berkeley Massachusetts Institute of Technology Ralph Baric Roger Brent University of North Carolina Fred Hutchinson Cancer Research Center Tom Burkett Sarah Carter Baltimore Underground Science Space Science Policy Consulting Susan Coller-Monarez Patrik D'haeseleer U.S. Department of Health and Human Lawrence Livermore National Laboratory Services Drew Endy Gerald L. Epstein Stanford University Office of Science and Technology Policy Aaron P. Esser-Kahn Carolyn M. Floyd University of California, Irvine Office of the Director of National Intelligence John Glass D. Christian Hassell J. Craig Venter Institute U.S. Department of Defense Michael Jewett CDR Franca Jones Northwestern University Global Emerging Infections Surveillance and Response System Lawrence Kerr Gregory Koblentz U.S. Department of Health and Human George Mason University Services George Korch Sriram Kosuri U.S. Department of Health and Human University of California, Los Angeles Services Jens H. Kuhn Todd Kuiken North Carolina State University PREPUBLICATION COPY: UNCORRECTED PROOFS

221 Biodefense in the Age of Synthetic Biology NIH/NIAID Integrated Research Facility at Fort Detrick Devin Leake Monique Mansoura Ginkgo Bioworks Massachusetts Institute of Technology Paul Miller Piers Millett Synlogic Biosecure, Ltd. Steve Monroe Richard Murray U.S. Centers for Disease Control and California Institute of Technology Prevention Megan Palmer Colin Parrish Stanford University Cornell University Amy Rasley Howard Salis Lawrence Livermore National Laboratory The Pennsylvania State University Dan Tawfik Luke Vandenberghe Weizmann Institute of Science, Israel Harvard University Harry Yim Genomatica PREPUBLICATION COPY: UNCORRECTED PROOFS

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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.

Biodefense in the Age of Synthetic Biology explores and envisions potential misuses of synthetic biology. This report develops a framework to guide an assessment of the security concerns related to advances in synthetic biology, assesses the levels of concern warranted for such advances, and identifies options that could help mitigate those concerns.

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