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
Washington, DC
www.nap.edu

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: 978-0-309-49567-7
International Standard Book Number-10: 0-309-49567-9
Digital Object Identifier: https://doi.org/10.17226/25525
Library of Congress Control Number: 2020930894

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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. https://doi.org/10.17226/25525.

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, 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 M. 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

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:

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.

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 of 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 provided the impetus for the 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 B) 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.

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 recommending 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

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Contents

SUMMARY

1 INTRODUCTION

History of the U.S. Bioeconomy

Advances in Biotechnology and the Life Sciences

Four Drivers of the U.S. Bioeconomy

Considerations in Safeguarding the U.S. Bioeconomy

Study Charge, Scope, and Approach

Organization of the Report

References

PART 1: DEFINING AND MEASURING THE U.S. BIOECONOMY

2 DEFINING THE U.S. BIOECONOMY

The Bioeconomy: Alternative Definitions

Defining the Bioeconomy Landscape in the United States

Conclusions

References

3 FRAMEWORKS FOR MEASURING THE VALUE OF THE U.S. BIOECONOMY

Characterizing the Bioeconomy for Economic Analysis

Measuring the Bioeconomy: Approaches for Valuation and Identification of Bioeconomy Intangible Assets

Direction of the U.S. Bioeconomy

Conclusions

Annex 3-1: Studies of the Industrial Bioeconomy (Including Agriculture)

Annex 3-2: Identifying Intangible Assets

References

4 AREAS OF LEADERSHIP IN THE GLOBAL ECONOMY

Leadership in Science in the Bioeconomy

National Comparisons of Private Innovation Inputs

National Comparisons of Innovation in Biotechnology and Other Areas of the Bioeconomy

National Comparisons of Entrepreneurship/Venture Capital Funding

U.S. Leadership Case Study: Synthetic Biology

U.S. Leadership in the Bioeconomy: Synthesis

Conclusions

References

PART II: UNDERSTANDING THE ECOSYSTEM AND IDENTIFYING NEW TRENDS IN THE U.S. BIOECONOMY

5 THE ECOSYSTEM OF THE U.S. BIOECONOMY

Innovation in the Bioeconomy: From Research to Application

The Surrounding Ecosystem Supporting the U.S. Bioeconomy

Trends and Changes in the Bioeconomy

Strategic Planning in Support of the U.S. Bioeconomy

Conclusions

References

6 HORIZON SCANNING AND FORESIGHT METHODS

Horizon Scanning as a Policy Tool

Good Practices in Horizon Scanning

Case Studies of Horizon Scanning

Additional Tools for Future Thinking

Conclusions

Annex 6-1: Defining Horizon Scanning

References

PART III: UNDERSTANDING THE RISKS ASSOCIATED WITH THE U.S. BIOECONOMY

7 ECONOMIC AND NATIONAL SECURITY RISKS PERTAINING TO THE BIOECONOMY

Failure to Promote the Bioeconomy

Failure to Protect the Bioeconomy or to Protect from Harms Mediated by the Bioeconomy

Conclusions

References

PART IV: STRATEGIES FOR SAFEGUARDING THE U.S. BIOECONOMY

8 OVERALL CONCLUSIONS AND RECOMMENDATIONS

Defining the U.S. Bioeconomy

Measuring the U.S. Bioeconomy

Safeguarding the U.S. Bioeconomy

Opportunities for International Engagement

References

APPENDIXES

A COMMITTEE BIOGRAPHIES

B INVITED SPEAKERS

C PARTICIPATING BOARDS

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