National Academies Press: OpenBook

Safeguarding the Bioeconomy (2020)

Chapter: Front Matter

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2020. Safeguarding the Bioeconomy. Washington, DC: The National Academies Press. doi: 10.17226/25525.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2020. Safeguarding the Bioeconomy. Washington, DC: The National Academies Press. doi: 10.17226/25525.
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PREPUBLICATION COPY Safeguarding the Bioeconomy Committee on Safeguarding the Bioeconomy: Finding Strategies for Understanding, Evaluating, and Protecting the Bioeconomy While Sustaining Innovation and Growth Board on Life Sciences Board on Agriculture and Natural Resources Division on Earth and Life Studies Board on Science, Technology, and Economic Policy Policy and Global Affairs Board on Health Sciences Policy Health and Medicine Division Forum on Cyber Resilience Division on Engineering and Physical Sciences A Consensus Study Report of

THE NATIONAL ACADEMIES PRESS 500 Fifth Street, NW Washington, DC 20001 This activity was supported by the Office of the Director of National Intelligence under Award Number WC133R17CQ0031. Any opinions, findings, conclusions, or recommendations expressed in this publication do not necessarily reflect the views of any organization or agency that provided support for the project. International Standard Book Number-13: 978-0-309-XXXXX-X International Standard Book Number-10: 0-309-XXXXX-X Digital Object Identifier: https://doi.org/10.17226/25525 Additional copies of this report are available from the National Academies Press, 500 Fifth Street, NW, Keck 360, Washington, DC 20001; (800) 624-6242 or (202) 334-3313; http://www.nap.edu/. Copyright 2020 by the National Academy of Sciences. All rights reserved. Printed in the United States of America Suggested citation: National Academies of Sciences, Engineering, and Medicine. 2020. Safeguarding the Bioeconomy. Washington, DC: The National Academies Press. doi: https://doi.org/10.17226/25525. Prepublication Copy

The National Academy of Sciences was established in 1863 by an Act of Congress, signed by President Lincoln, as a private, nongovernmental institution to advise the nation on issues related to science and technology. Members are elected by their peers for outstanding contributions to research. Dr. Marcia McNutt is president. The National Academy of Engineering was established in 1964 under the charter of the National Academy of Sciences to bring the practices of engineering to advising the nation. Members are elected by their peers for extraordinary contributions to engineering. Dr. John L. Anderson is president. The National Academy of Medicine (formerly the Institute of Medicine) was established in 1970 under the charter of the National Academy of Sciences to advise the nation on medical and health issues. Members are elected by their peers for distinguished contributions to medicine and health. Dr. Victor J. Dzau is president. The three Academies work together as the National Academies of Sciences, Engineering, and Medicine to provide independent, objective analysis and advice to the nation and conduct other activities to solve complex problems and inform public policy decisions. The Academies also encourage education and research, recognize outstanding contributions to knowledge, and increase public understanding in matters of science, engineering, and medicine. Learn more about the National Academies of Sciences, Engineering, and Medicine at www.nationalacademies.org. Prepublication Copy

Consensus Study Reports published by the National Academies of Sciences, Engineering, and Medicine document the evidence-based consensus on the study’s statement of task by an authoring committee of experts. Reports typically include findings, conclusions, and recommendations based on information gathered by the committee and the committee’s deliberations. Each report has been subjected to a rigorous and independent peer-review process and it represents the position of the National Academies on the statement of task. Proceedings published by the National Academies of Sciences, Engineering, and Medicine chronicle the presentations and discussions at a workshop, symposium, or other event convened by the National Academies. The statements and opinions contained in proceedings are those of the participants and are not endorsed by other participants, the planning committee, or the National Academies. For information about other products and activities of the National Academies, please visit www.nationalacademies.org/about/whatwedo. Prepublication Copy

COMMITTEE ON SAFEGUARDING THE BIOECONOMY: FINDING STRATEGIES FOR UNDERSTANDING, EVALUATING, AND PROTECTING THE BIOECONOMY WHILE SUSTAINING INNOVATION AND GROWTH THOMAS M. CONNELLY, JR., Chair, American Chemical Society, Washington, DC STEVEN M. BELLOVIN, Columbia University, New York, New York PATRICK M. BOYLE, Ginkgo Bioworks Inc., Boston, Massachusetts KATHERINE CHARLET, Carnegie Endowment for International Peace, Washington, DC CAROL CORRADO, The Conference Board, New York J. BRADLEY DICKERSON, Sandia National Laboratories, Albuquerque, New Mexico DIANE DIEULIIS, National Defense University, Washington, DC GERALD EPSTEIN, National Defense University, Washington, DC STEVEN L. EVANS, Dow Agro Science (retired), Indianapolis, Indiana GEORGE B. FRISVOLD, University of Arizona, Tucson JEFFREY L. FURMAN, Boston University, Boston, Massachusetts LINDA KAHL, SciScript Communications, Walnut Creek, California ISAAC S. KOHANE, Harvard Medical School, Boston, Massachusetts KELVIN H. LEE, University of Delaware, Newark MARY E. MAXON, Lawrence Berkeley National Laboratory, Berkeley, California MAUREEN MCCANN, Purdue University, West Lafayette, Indiana PIERS D. MILLETT, iGEM, Boston, Massachusetts Staff ANDREA HODGSON, Study Director, Board on Life Sciences FRANCES SHARPLES, Board Director, Board on Life Sciences KATHERINE BOWMAN, Senior Program Officer, Board on Life Sciences STEVEN MOSS, Associate Program Officer, Board on Life Sciences KOSSANA YOUNG, Senior Program Assistant, Board on Life Sciences KARA LANEY, Senior Program Officer, Board on Agriculture and Natural Resources GAIL COHEN, Board Director, Board on Science, Technology, and Economic Policy STEVEN KENDALL, Program Officer, Board on Science, Technology, and Economic Policy SCOTT WOLLEK, Senior Program Officer, Board on Health Sciences Policy LYNETTE MILLETT, Director, Forum on Cyber Resilience Consultants RONA BRIERE, Editor ALISA DECATUR, Editorial Assistant Prepublication Copy v

Acknowledgments This Consensus Study Report was greatly enhanced by discussions with participants at the committee’s meetings and workshops as part of this study (a full list of participants is available in Appendix B). The committee would particularly like to acknowledge the efforts of those who contributed to its information-gathering efforts through personal discussions, informal requests for information, or some other mechanism: Laura Haas, University of Massachusetts Amherst; Tony Sager, Center for Internet Security; and Fred Schneider, Cornell University. This Consensus Study Report was reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise. The purpose of this independent review is to provide candid and critical comments that will assist the National Academies of Sciences, Engineering, and Medicine in making each published report as sound as possible and to ensure that it meets the institutional standards for quality, objectivity, evidence, and responsiveness to the study charge. The review comments and draft manuscript remain confidential to protect the integrity of the deliberative process. The committee thanks the following individuals for their review of this report: Patricia Brennan, National Library of Medicine John Cumbers, SynBioBeta Drew Endy, Stanford University Richard B. Freeman, Harvard University Michelle Garfinkel, EMBO Val Giddings, Information Technology and Innovation Foundation Andy Hines, University of Houston Joseph Kanabrocki, The University of Chicago Steven B. Lipner, SAFECode Ben Petro, U.S. Department of Defense Gene Robinson, University of Illinois at Urbana-Champaign Howard B. Rosen, Independent Consultant Philip P. Shapira, University of Manchester Darlene Solomon, Agilent Samuel S. Visner, MITRE Corporation David Zilberman, University of California, Berkeley Although the reviewers listed above provided many constructive comments and suggestions, they were not asked to endorse the conclusions or recommendations of this report, nor did they see the final draft before its release. The review of this report was overseen by Michael R. Ladisch, Purdue University, and Peter Carr, Massachusetts Institute of Technology. They were responsible for making certain that an independent examination of this report was carried out in accordance with the standards of the National Academies and that all review comments were carefully considered. Responsibility for the final content rests entirely with the authoring committee and the National Academies. Prepublication Copy vii

Preface The U.S. bioeconomy comprises exciting science and technology-driven economic activity that is expanding and advancing on many fronts. Americans’ everyday lives benefit from the U.S. bioeconomy in terms of the food they eat, the health care they receive; the quality of their environment; and the fuels, materials, and products they consume, and the bioeconomy is poised to make even larger contributions in all of these sectors and possibly some additional areas as well. U.S. science and technology are the source of all these benefits. Fueled by public and private investment, the nation has maintained a considerable technological lead in the bioeconomy domain, and for an extended period of time. At the same time, the powerful technologies encompassed by the bioeconomy can also lead to national security and economic vulnerabilities. For example, biotechnology can be misused to create virulent pathogens that can target our food supply (crops and animals), or even the human population. Engineering biology can be used to eliminate invasive species, yet such actions can have unintended environmental consequences. Genomic technology can be used to design disease therapies that are tailored to an individual, yet this same technology can be used to identify genetic vulnerabilities in a population or subpopulation. Large genetic databases allow people’s ancestry to be revealed and crimes to be solved, but such data can also be misused. And while genetic and other large datasets contribute to medical progress, they also represent potential security and privacy concerns. During the past decade, moreover, competition in the global bioeconomy has intensified. Although economic competition has always been part of global commerce, global competition has in some respects moved beyond the usual economic rivalry among nations. Outright theft of intellectual property and know-how has occurred in some cases. Cross-border cyber intrusion has led to exfiltration of proprietary information and data from U.S. organizations by individuals and entities in other countries. More subtle loss of competitiveness can also occur. As a result of some countries’ policies, an asymmetry exists in the way information is shared, whereby the ability of U.S.-based researchers to access and use such information is denied. While one response is retaliation with similar policies, this response would be counter to the system that gave rise to the global bioeconomy and the broader scientific enterprise. The entire world has benefited from the exchange of scientific information built on collaborative efforts of scientists around the world. These security and economic concerns provide the impetus for this study documented in this report, which was requested by the Office of the Director of National Intelligence. To carry out the study, the National Academies of Sciences, Engineering, and Medicine convened the Committee on Safeguarding the Bioeconomy: Finding Strategies for Understanding, Evaluating, and Protecting the Bioeconomy While Sustaining Innovation and Growth. Convened in December 2018, the 17-member committee was charged with investigating strategies for understanding, evaluating, and protecting the bioeconomy while sustaining innovation and growth. Given the breadth of this task, the committee’s membership represents a broad range of expertise, including life sciences, engineering, computer science, economics, law, strategic planning, and national security. The committee members have current or past experience in academia, federal agencies, national laboratories, nongovernmental organizations, and industry (large and entrepreneurial companies), and have worked in many bioeconomy sectors, including human health, pharmaceuticals, agriculture, and industrial bioscience. The committee met four times in face-to-face meetings between January and June 2019. Three of these meetings included open workshop sessions. An additional three webinars were held to which the public was also invited. During these meetings and webinars, the committee heard from a total of 36 speakers (see Appendix D) on every facet of the U.S. bioeconomy. In addition, the committee members met privately in numerous conference calls, both as a full committee and in small groups. Prepublication Copy ix

Preface The work of this committee was ably assisted by the essential support of the staff of the National Academies. Given the breadth of our task, significant contributions were made by staff from the Board on Life Sciences; the Board on Agriculture and Natural Resources; the Board on Science, Technology, and Economic Policy; the Board on Health Sciences Policy; and the Forum on Cyber Resilience. This study could not have been completed without their outstanding efforts. The committee especially wishes to acknowledge the guidance and leadership of study director Andrea Hodgson. The committee’s task was daunting in scope. As noted above, it was charged with developing strategies for understanding and evaluating the U.S. bioeconomy, as well as to recommend strategies for protecting the bioeconomy while sustaining innovation and growth. Central to our work were the somewhat opposed notions of safeguarding and growth, of security and openness. Science and innovation thrive when ideas, information, products, services, and data are freely exchanged. The United States has an open and welcoming culture. As a nation, it is open by intent and by preference, and it has benefited enormously from this openness. In all aspects of the committee’s deliberations, as it strove for consensus in its recommendations, the need to address security concerns while preserving the benefits of openness was a primary consideration. The committee recognizes that international collaborations are essential to the continued success of the U.S. bioeconomy. While the choices are not always easy, prudent decisions can be made. The committee does believe in the nation’s ability both to safeguard the bioeconomy and to further its growth. In our view, the recommendations presented in this report can serve as important steps toward fully realizing the promise and potential of the U.S. bioeconomy. Thomas M. Connelly, Jr., Chair Committee on Safeguarding the Bioeconomy: Finding Strategies for Understanding, Evaluating, and Protecting the Bioeconomy While Sustaining Innovation and Growth x Prepublication Copy

Contents SUMMARY ......................................................................................................................................................... 1 1 INTRODUCTION ...................................................................................................................................... 12 History of the U.S. Bioeconomy, 13 Advances in Biotechnology and the Life Sciences, 15 Four Drivers of the U.S. Bioeconomy, 19 Considerations in Safeguarding the U.S. Bioeconomy, 20 Study Charge, Scope, and Approach, 21 References, 23 PART 1: DEFINING AND MEASURING THE U.S. BIOECONOMY ...................................................... 26 2 DEFINING THE U.S. BIOECONOMY................................................................................................... 27 The Bioeconomy: Alternative Definitions, 29 Defining the Bioeconomy Landscape, 35 Defining the Bioeconomy Landscape in the United States, 38 Conclusions, 42 References, 43 3 FRAMEWORKS FOR MEASURING THE VALUE OF THE U.S. BIOECONOMY ....................... 49 Characterizing the Bioeconomy for Economic Analysis, 50 Measuring the Bioeconomy: Approaches for Valuation and Identification of Bioeconomy Intangible Assets, 55 Direction of the U.S. Bioeconomy, 72 Conclusions, 90 Annex 3-1: Studies of the Industrial Bioeconomy (Including Agriculture), 93 Annex 3-2: Identifying Intangible Assets, 98 References, 101 4 AREAS OF LEADERSHIP IN THE GLOBAL ECONOMY .............................................................. 104 Leadership in Science in the Bioeconomy, 104 National Comparisons of Private Innovation Inputs, 111 National Comparisons of Innovation in Biotechnology and Other Areas of the Bioeconomy, 112 National Comparisons of Entrepreneurship/Venture Capital Funding, 117 U.S. Leadership Case Study: Synthetic Biology, 119 U.S. Leadership in the Bioeconomy: Synthesis, 122 Conclusions, 123 References, 123 PART II: UNDERSTANDING THE ECOSYSTEM AND IDENTIFYING NEW TRENDS IN THE U.S. BIOECONOMY ...................................................................................................... 126 5 THE ECOSYSTEM OF THE U.S. BIOECONOMY ............................................................................ 127 Innovation in the Bioeconomy: From Research to Application, 127 The Surrounding Ecosystem Supporting the U.S. Bioeconomy, 131 Trends and Changes in the Bioeconomy, 141 Strategic Planning in Support of the U.S. Bioeconomy, 152 Prepublication Copy xi

Contents Conclusions, 154 References, 155 6 HORIZON SCANNING AND FORESIGHT METHODS ................................................................... 160 Horizon Scanning as a Policy Tool, 161 Good Practices in Horizon Scanning, 162 Case Studies of Horizon Scanning, 165 Additional Tools for Future Thinking, 168 Conclusions, 170 Annex 6-1: Defining Horizon Scanning, 174 References, 184 PART III: UNDERSTANDING THE RISKS ASSOCIATED WITH THE U.S. BIOECONOMY ........ 187 7 ECONOMIC AND NATIONAL SECURITY RISKS PERTAINING TO THE BIOECONOMY ... 188 Failure to Promote the Bioeconomy, 189 Failure to Protect the Bioeconomy or to Protect from Harms Mediated by the Bioeconomy, 198 Conclusions, 221 References, 222 PART IV: STRATEGIES FOR SAFEGUARDING THE U.S. BIOECONOMY..................................... 228 8 OVERALL CONCLUSIONS AND RECOMMENDATIONS ............................................................. 229 Defining the U.S. Bioeconomy, 229 Measuring the U.S. Bioeconomy, 230 Safeguarding the U.S. Bioeconomy, 234 Opportunities for International Engagement, 241 References, 242 APPENDIXES A COMMITTEE BIOGRAPHIES.............................................................................................................. 243 B INVITED SPEAKERS ............................................................................................................................. 248 C PARTICIPATING BOARDS .................................................................................................................. 250 xii Prepublication Copy

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Research and innovation in the life sciences is driving rapid growth in agriculture, biomedical science, information science and computing, energy, and other sectors of the U.S. economy. This economic activity, conceptually referred to as the bioeconomy, presents many opportunities to create jobs, improve the quality of life, and continue to drive economic growth. While the United States has been a leader in advancements in the biological sciences, other countries are also actively investing in and expanding their capabilities in this area. Maintaining competitiveness in the bioeconomy is key to maintaining the economic health and security of the United States and other nations.

Safeguarding the Bioeconomy evaluates preexisting and potential approaches for assessing the value of the bioeconomy and identifies intangible assets not sufficiently captured or that are missing from U.S. assessments. This study considers strategies for safeguarding and sustaining the economic activity driven by research and innovation in the life sciences. It also presents ideas for horizon scanning mechanisms to identify new technologies, markets, and data sources that have the potential to drive future development of the bioeconomy.

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