Committee on Strategies for Identifying and Addressing Potential Biodefense Vulnerabilities Posed by Synthetic Biology

Board on Chemical Sciences and Technology

Board on Life Sciences

Division on Earth and Life Studies

THE NATIONAL ACADEMIES PRESS
Washington, DC
www.nap.edu

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This project was supported by Contract No. HQ0034-16-C-0062 between the National Academy of Sciences and the U.S. Department of Defense. Any opinions, findings, conclusions, or recommendations expressed in this publication do not necessarily reflect the view of any organization or agency that provided support for the project.

International Standard Book Number-13: 978-0-309-46518-2
International Standard Book Number-10: 0-309-46518-4
Library of Congress Control Number: 2018911261
Digital Object Identifier: https://doi.org/10.17226/24890

Copyright 2018 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. 2018. Biodefense in the Age of Synthetic Biology. Washington, DC: The National Academies Press. doi: https://doi.org/10.17226/24890.

COMMITTEE ON STRATEGIES FOR IDENTIFYING AND ADDRESSING POTENTIAL BIODEFENSE VULNERABILITIES POSED BY SYNTHETIC BIOLOGY

Members

MICHAEL IMPERIALE (Chair), University of Michigan Medical School

PATRICK BOYLE,¹ Ginkgo Bioworks

PETER A. CARR, Massachusetts Institute of Technology Lincoln Laboratory

DOUGLAS DENSMORE, Boston University

DIANE DIEULIIS, National Defense University

ANDREW ELLINGTON, University of Texas at Austin

GIGI KWIK GRONVALL, Johns Hopkins Center for Health Security

CHARLES HAAS, Drexel University

JOSEPH KANABROCKI, University of Chicago

KARA MORGAN, Quant Policy Strategies, LLC

KRISTALA JONES PRATHER, Massachusetts Institute of Technology

THOMAS SLEZAK, Lawrence Livermore National Laboratory

JILL TAYLOR, New York State Department of Health

Staff

MARILEE SHELTON-DAVENPORT, Study Director

KATHERINE BOWMAN, Senior Program Officer

JENNA OGILVIE, Research Associate

JARRETT NGUYEN, Senior Program Assistant

___________________

¹ See Appendix E, Disclosure of Conflict of Interest.

BOARD ON CHEMICAL SCIENCES AND TECHNOLOGY

Co-Chairs

DAVID BEM, PPG Industries

JOAN BRENNECKE, NAE, University of Texas, Austin

Members

GERARD BAILLELY, Procter and Gamble

MARK A. BARTEAU, NAE, Texas A&M

MICHELLE V. BUCHANAN, Oak Ridge National Laboratory

JENNIFER SINCLAIR CURTIS, University of California, Davis

RICHARD EISENBERG, NAS, University of Rochester

SAMUEL H. GELLMAN, NAS, University of Wisconsin–Madison

SHARON C. GLOTZER, NAS, University of Michigan

MIRIAM E. JOHN, Sandia National Laboratories (retired)

ALAN D. PALKOWITZ, Eli Lilly and Company (retired)

JOSEPH B. POWELL, Shell

PETER J. ROSSKY, NAS, Rice University

RICHMOND SARPONG, University of California, Berkeley

TIMOTHY SWAGER, NAS, Massachusetts Institute of Technology

National Academies of Sciences, Engineering, and Medicine Staff

TERESA FRYBERGER, Board Director

MARILEE SHELTON-DAVENPORT, Senior Program Officer

CAMLY TRAN, Senior Program Officer

ANNA SBEREGAEVA, Associate Program Officer

JARRETT I. NGUYEN, Senior Program Assistant

JESSICA WOLFMAN, Senior Program Assistant

SHUBHA BANSKOTA, Financial Associate

BOARD ON LIFE SCIENCES

Chair

JAMES P. COLLINS, Arizona State University

Members

ALONSO AGUIRRE, George Mason University

ENRIQUETA C. BOND, Burroughs Wellcome Fund

DOMINIQUE BROSSARD, University of Wisconsin-Madison

ROGER D. CONE, University of Michigan

NANCY D. CONNELL, Rutgers New Jersey Medical School

SEAN M. DECATUR, Kenyon College

JOSEPH R. ECKER, Salk Institute for Biological Studies

SCOTT V. EDWARDS, Harvard University

GERALD L. EPSTEIN, National Defense University

ROBERT J. FULL, University of California, Berkeley

ELIZABETH HEITMAN, Vanderbilt University Medical Center

JUDITH KIMBLE, University of Wisconsin–Madison

MARY E. MAXON, Lawrence Berkeley National Laboratory

ROBERT NEWMAN, Independent Consultant

STEPHEN J. O’BRIEN, Nova Southeastern University

CLAIRE POMEROY, Albert and Mary Lasker Foundation

MARY E. POWER, University of California, Berkeley

SUSAN RUNDELL SINGER, University of California, Berkeley

LANA SKIRBOLL, Sanofi

DAVID R. WALT, Harvard Medical School

Staff

FRANCES SHARPLES, Director

KATHERINE BOWMAN, Senior Program Officer

ANDREA HODGSON, Program Officer

JO HUSBANDS, Senior Scholar

KEEGAN SAWYER, Senior Program Officer

AUDREY THEVENON, Program Officer

JESSICA DE MOUY, Senior Program Assistant

KOSSANA YOUNG, Senior Program Assistant

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Acknowledgment of Reviewers

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.

We thank 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 LADISCH, Purdue University, and RANDALL MURCH, Virginia Polytechnic and State University. 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.

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Contents

SUMMARY

1 INTRODUCTION

Understanding Synthetic Biology

Assessing Potential Biodefense Concerns

Mitigating Potential Biodefense Concerns

Study Approach

2 BIOTECHNOLOGY IN THE AGE OF SYNTHETIC BIOLOGY

What Is Synthetic Biology

Implications of the Age of Synthetic Biology

Specific Synthetic Biology Technologies and Applications

3 FRAMEWORK FOR ASSESSING CONCERN ABOUT SYNTHETIC BIOLOGY CAPABILITIES

Approach to Developing the Framework

Factors for Assessing Concern

Applying the Framework in the Assessment of Concern

4 ASSESSMENT OF CONCERNS RELATED TO PATHOGENS

Re-Creating Known Pathogens

Making Existing Pathogens More Dangerous

Creating New Pathogens

Summary

5 ASSESSMENT OF CONCERNS RELATED TO PRODUCTION OF CHEMICALS OR BIOCHEMICALS

Manufacturing Chemicals or Biochemicals by Exploiting Natural Metabolic Pathways

Manufacturing Chemicals or Biochemicals by Creating Novel Metabolic Pathways

Making Biochemicals via In Situ Synthesis

Summary

6 ASSESSMENT OF CONCERNS RELATED TO BIOWEAPONS THAT ALTER THE HUMAN HOST

Modifying the Human Microbiome

Modifying the Human Immune System

Modifying the Human Genome

Summary

7 RELATED DEVELOPMENTS THAT MAY IMPACT THE ABILITY TO EFFECT AN ATTACK USING A SYNTHETIC BIOLOGY–ENABLED WEAPON

Barriers to the Use of Bioweapons

Relevant Convergent Technologies

Summary

8 OPTIONS FOR MITIGATING CONCERNS

Current Mitigation Approaches and Infrastructure

Mitigation Challenges Posed by Synthetic Biology

Potential Opportunities to Advance Mitigation Capabilities

Summary

9 MOVING FORWARD: CONCLUSIONS AND RECOMMENDATIONS

Overarching Recommendation

Concerns Posed by Synthetic Biology–Enabled Capabilities

Future Use of the Framework

Biodefense Implications of the Age of Synthetic Biology

REFERENCES

APPENDIXES

A Specific Synthetic Biology Concepts, Approaches, and Tools

B Selected Prior Analyses Used to Inform the Framework

C Questions to Stimulate Consideration of Framework Factors

D Committee Biographies

E Disclosure of Conflict of Interest

F Study Methods