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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2017. Preparing for Future Products of Biotechnology. Washington, DC: The National Academies Press. doi: 10.17226/24605.
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Preparing for

Future Products

of Biotechnology

Committee on Future Biotechnology Products and Opportunities to
Enhance Capabilities of the Biotechnology Regulatory System

Board on Life Sciences

Board on Agriculture and Natural Resources

Board on Chemical Sciences and Technology

Division on Earth and Life Studies

A Report of

images

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

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2017. Preparing for Future Products of Biotechnology. Washington, DC: The National Academies Press. doi: 10.17226/24605.
×

THE NATIONAL ACADEMIES PRESS 500 Fifth Street, NW Washington, DC 20001

This activity was supported by Contract No. EP-C-14-005 with the U.S. Environmental Protection Agency. 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: 978-0-309-45205-2
International Standard Book Number-10: 0-309-45205-8
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Library of Congress Control Number: 2017940892

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Suggested citation: National Academies of Sciences, Engineering, and Medicine. 2017. Preparing for Future Products of Biotechnology. Washington, DC: The National Academies Press. doi: https://doi.org/10.17226/24605.

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2017. Preparing for Future Products of Biotechnology. Washington, DC: The National Academies Press. doi: 10.17226/24605.
×

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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. C. D. Mote, Jr., 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 National 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.national-academies.org.

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2017. Preparing for Future Products of Biotechnology. Washington, DC: The National Academies Press. doi: 10.17226/24605.
×

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Reports document the evidence-based consensus of an authoring committee of experts. Reports typically include findings, conclusions, and recommendations based on information gathered by the committee and committee deliberations. Reports are peer reviewed and are approved by the National Academies of Sciences, Engineering, and Medicine.

Proceedings chronicle the presentations and discussions at a workshop, symposium, or other convening event. The statements and opinions contained in proceedings are those of the participants and have not been endorsed by other participants, the planning committee, or the National Academies of Sciences, Engineering, and Medicine.

For information about other products and activities of the National Academies, please visit nationalacademies.org/whatwedo.

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2017. Preparing for Future Products of Biotechnology. Washington, DC: The National Academies Press. doi: 10.17226/24605.
×

COMMITTEE ON FUTURE BIOTECHNOLOGY PRODUCTS AND OPPORTUNITIES TO ENHANCE CAPABILITIES OF THE BIOTECHNOLOGY REGULATORY SYSTEM

Chair

RICHARD M. MURRAY, NAE1, California Institute of Technology, Pasadena

Members

RICHARD M. AMASINO, NAS2, University of Wisconsin–Madison

STEVEN P. BRADBURY, Iowa State University, Ames

BARBARA J. EVANS, University of Houston Law Center, Houston, TX

STEVEN L. EVANS, Dow AgroSciences, Indianapolis, IN

FARREN ISAACS, Yale University, New Haven, CT

RICHARD A. JOHNSON, NAS2, Global Helix LLC, Washington, DC (resigned August 2016)

MARTHA A. KREBS, The Pennsylvania State University, Philadelphia

JENNIFER KUZMA, North Carolina State University, Raleigh

MARY E. MAXON, Lawrence Berkeley National Laboratory, Emeryville, CA

RAUL F. MEDINA, Texas A&M University, College Station

DAVID REJESKI, Environmental Law Institute, Washington, DC

JEFFREY WOLT, Iowa State University, Ames

Staff

KARA N. LANEY, Study Director (from July 2016)

DOUGLAS FRIEDMAN, Study Director (through July 2016)

MARILEE K. SHELTON-DAVENPORT, Senior Program Officer

ANDREA HODGSON, Postdoctoral Fellow

JENNA BRISCOE, Senior Program Assistant

AANIKA SENN, Senior Program Assistant

FRANCES E. SHARPLES, Director, Board on Life Sciences

ROBIN A. SCHOEN, Director, Board on Agriculture and Natural Resources

TERESA FRYBERGER, Director, Board on Chemical Sciences and Technology

___________________

1 National Academy of Engineering.

2 National Academy of Sciences.

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2017. Preparing for Future Products of Biotechnology. Washington, DC: The National Academies Press. doi: 10.17226/24605.
×

BOARD ON LIFE SCIENCES

Chair

JAMES P. COLLINS, Arizona State University, Tempe

Members

ENRIQUETA C. BOND, NAM1, Burroughs Wellcome Fund, Marshall, VA

ROGER D. CONE, NAS2, University of Michigan, Ann Arbor

NANCY D. CONNELL, Rutgers New Jersey Medical School, Newark

JOSEPH R. ECKER, NAS2, Salk Institute for Biological Studies, La Jolla, CA

SARAH C. R. ELGIN, Washington University, St. Louis, MO

LINDA G. GRIFFITH, NAE3, Massachusetts Institute of Technology, Cambridge

ELIZABETH HEITMAN, University of Texas Southwestern Medical Center, Dallas

RICHARD A. JOHNSON, Global Helix LLC, Washington, DC

JUDITH KIMBLE, NAS2, University of Wisconsin–Madison

MARY E. MAXON, Lawrence Berkeley National Laboratory, Emeryville, CA

JILL P. MESIROV, University of California, San Diego

KAREN E. NELSON, J. Craig Venter Institute, Rockville, MD

CLAIRE POMEROY, NAM1, The Albert and Mary Lasker Foundation, New York, NY

MARY E. POWER, NAS2, University of California, Berkeley

MARGARET RILEY, University of Massachusetts, Amherst

LANA SKIRBOLL, Sanofi, Washington, DC

JANIS C. WEEKS, University of Oregon, Eugene

Staff

FRANCES E. SHARPLES, Director

JO L. HUSBANDS, Scholar/Senior Project Director

JAY B. LABOV, Senior Scientist/Program Director for Biology Education

KATHERINE W. BOWMAN, Senior Program Officer

KEEGAN SAWYER, Senior Program Officer

AUDREY THEVENON, Program Officer

ANDREA HODGSON, Postdoctoral Fellow

BETHELHEM M. MEKASHA, Financial Associate

JENNA OGILVIE, Research Associate

ANGELA KOLESNIKOVA, Senior Program Assistant

AANIKA SENN, Senior Program Assistant

___________________

1 National Academy of Medicine.

2 National Academy of Sciences.

3 National Academy of Engineering.

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2017. Preparing for Future Products of Biotechnology. Washington, DC: The National Academies Press. doi: 10.17226/24605.
×

BOARD ON AGRICULTURE AND NATURAL RESOURCES

Chair

CHARLES W. RICE, Kansas State University, Manhattan

Members

PEGGY F. BARLETT, Emory University, Atlanta, GA

SUSAN CAPALBO, Oregon State University, Corvallis

GAIL CZARNECKI-MAULDEN, Nestlé Purina PetCare, St. Louis, MO

GEBISA EJETA, Purdue University, West Lafayette, IN

ROBERT B. GOLDBERG, NAS1, University of California, Los Angeles

FRED GOULD, NAS1, North Carolina State University, Raleigh

MOLLY M. JAHN, University of Wisconsin–Madison

ROBBIN S. JOHNSON, Cargill Foundation, Wayzata, MN

A. G. KAWAMURA, Solutions from the Land, Washington, DC

STEPHEN S. KELLEY, North Carolina State University, Raleigh

JULIA L. KORNEGAY, North Carolina State University, Raleigh

JIM E. RIVIERE, NAM2, Kansas State University, Manhattan

Staff

ROBIN A. SCHOEN, Director

CAMILLA YANDOC ABLES, Program Officer

JENNA BRISCOE, Senior Program Assistant

KARA N. LANEY, Senior Program Officer

PEGGY TSAI YIH, Senior Program Officer

___________________

1 National Academy of Sciences.

2 National Academy of Medicine.

Page viii Cite
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2017. Preparing for Future Products of Biotechnology. Washington, DC: The National Academies Press. doi: 10.17226/24605.
×

BOARD ON CHEMICAL SCIENCES AND TECHNOLOGY

Co-Chairs

DAVID BEM, PPG Industries, Pittsburgh, PA

JOAN BRENNECKE, NAE1, Notre Dame University, South Bend, IN

Members

HÉCTOR D. ABRUÑA, Cornell University, Ithaca, NY

JOEL C. BARRISH, Achillion Pharmaceuticals, New Haven, CT

MARK BARTEAU, NAE1, University of Michigan, Ann Arbor

MICHELLE V. BUCHANAN, Oak Ridge National Laboratory, Oak Ridge, TN

DAVID W. CHRISTIANSON, University of Pennsylvania, Philadelphia

JENNIFER SINCLAIR CURTIS, University of California, Davis

RICHARD EISENBERG, NAS2, University of Rochester, New York

SAMUEL H. GELLMAN, NAS2, University of Wisconsin–Madison

SHARON C. GLOTZER, NAS2, University of Michigan, Ann Arbor

MIRIAM E. JOHN, Sandia National Laboratories (Retired), Livermore, CA

FRANCES S. LIGLER, NAE1, University of North Carolina at Chapel Hill and North Carolina State University, Raleigh

SANDER G. MILLS, Merck Research Laboratories (Retired), Rahway, NJ

JOSEPH B. POWELL, Shell, Houston, TX

PETER J. ROSSKY, NAS2, Rice University, Houston, TX

TIMOTHY SWAGER, NAS2, Massachusetts Institute of Technology, Cambridge

Staff

TERESA FRYBERGER, Director

MARILEE K. SHELTON-DAVENPORT, Senior Program Officer

CAMLY TRAN, Program Officer

ANNA SBEREGAEVA, Associate Program Officer

SUZANNE THILENIUS, Administrative Coordinator

SHUBHA BANSKOTA, Financial Associate

JARRET NGUYEN, Program Assistant

___________________

1 National Academy of Engineering.

2 National Academy of Sciences.

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2017. Preparing for Future Products of Biotechnology. Washington, DC: The National Academies Press. doi: 10.17226/24605.
×

Preface

The Coordinated Framework for Regulation of Biotechnology is the U.S. government’s mechanism for providing oversight for the diverse array of products of biotechnology that are being brought to market in a manner that protects health and the environment. In light of some of the recent advances in biotechnology, including in genome editing, gene drives, and synthetic biology, the federal government is in the process of making much needed updates to the Coordinated Framework, which had its last major revision in 1992. The task of this committee was to look into the future and describe the possible products of biotechnology that will arise over the next 5–10 years, as well as provide some insights that can help shape the capabilities within the agencies as they move forward. Given the rapid (and often unforeseen) advances of the past 5–10 years, it is clear that making accurate predictions of what will be possible is a difficult task, but some trends are clear: there will be a profusion of new products that will in many cases be very different in terms of their type, scope, and complexity, and the number of actors who will be able to contribute to biotechnology will be even more diverse as engineering biology becomes more accessible. At the same time, there is increased public awareness (and in some cases controversy), and the regulatory agencies are faced with the challenge of balancing the many competing interests from industry, society, government, and academia.

This report reflects the committee’s deliberations regarding the future products of biotechnology that are likely to appear on the horizon, the challenges that the regulatory agencies might face, and the opportunities for enhancing the regulatory system to be prepared for what might be coming. The committee reached consensus on conclusions and recommendations that are based on extensive information gathering, committee discussions, and input from a wide variety of communities interested in biotechnology. The committee contained a diverse set of experts, including individuals with experience in natural sciences and engineering, law and public policy, social sciences, and risk assessment.

This report would not have been possible without the exceptional contributions of the National Academies of Sciences, Engineering, and Medicine staff members: Kara Laney, Marilee Shelton-Davenport, Andrea Hodgson, Jenna Briscoe, and Doug Friedman. Aanika Senn provided the committee with outstanding logistical support. We acknowledge gratefully all of their efforts.

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2017. Preparing for Future Products of Biotechnology. Washington, DC: The National Academies Press. doi: 10.17226/24605.
×

A special thanks to my colleagues on the committee for their robust opinions and thoughtful discussions that helped shape the conclusions and recommendations that we reached. It was a pleasure to work with this outstanding group of experts.

Richard M. Murray, Chair
Committee on Future Biotechnology Products and
Opportunities to Enhance Capabilities of the Biotechnology
Regulatory System

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2017. Preparing for Future Products of Biotechnology. Washington, DC: The National Academies Press. doi: 10.17226/24605.
×

Acknowledgments

This report is a product of the cooperation and contribution of many people. The members of the committee thank all the speakers who participated in the committee’s meetings. (Appendix B contains a list of presentations to the committee.) The committee also wishes to thank all the agency officials who provided responses to the committee’s request for information. (Appendix C contains a list of agencies sent the request.) In addition, the committee expresses its gratitude to Dr. Sarah Carter for her contributions to the committee’s information-gathering process.

This report has been 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 institution in making its published report as sound as possible and to ensure that the report meets institutional standards for objectivity, evidence, and responsiveness to the study charge. The review comments and draft manuscript remain confidential to protect the integrity of the process. We wish to thank the following individuals for their review of this report:

Lynn Bergeson, Bergeson & Campbell, PC

Yann Devos, European Food Safety Authority

Thomas Dietz, Michigan State University

Robert Friedman, J. Craig Venter Institute

Keith Hayes, Commonwealth Scientific and Industrial Research Organisation, Australia

Jennifer R. Holmgren, LanzaTech

Peter Barton Hutt, Covington & Burling LLP

Michael Jewett, Northwestern University

Sally Katzen, New York University School of Law

James Liao, Academia Sinica

Phil MacDonald, Canadian Food Inspection Agency

Joachim Messing, Waksman Institute of Microbiology

Warren Muir, Granite Research Institute

D. Warner North, NorthWorks

Reshma Shetty, Ginkgo Bioworks, Inc.

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2017. Preparing for Future Products of Biotechnology. Washington, DC: The National Academies Press. doi: 10.17226/24605.
×

C. Neal Stewart, University of Tennessee

Daniel Voytas, University of Minnesota

Although reviewers listed above have provided many constructive comments and suggestions, they were not asked to endorse the report’s conclusions or recommendations, nor did they see the final draft of the report before the release. The review of this report was overseen by Lynn Goldman, The George Washington University, and Deborah Delmer, University of California, Davis. They were responsible for making certain than an independent examination of this report was carried out in accordance with institutional procedures and that all review comments were carefully considered. Responsibility for the final content of this report rests entirely with the authoring committee and the institution.

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2017. Preparing for Future Products of Biotechnology. Washington, DC: The National Academies Press. doi: 10.17226/24605.
×

Select Acronyms and Abbreviations

AHPA Animal Health Protection Act
APHIS Animal and Plant Health Inspection Service
ARS Agricultural Research Service
BRAG Biotechnology Risk Assessment Grants
Bt Bacillus thuringiensis
BWG Biotechnology Working Group
CAD Computer-Aided Design
Cas9 CRISPR-Associated Protein 9
CDC Centers for Disease Control and Prevention
CPSC Consumer Product Safety Commission
CRISPR Clustered Regularly Interspaced Short Palindromic Repeat
CSIRO Commonwealth Scientific and Industrial Research Organisation
DARPA Defense Advanced Research Projects Agency
DBTL Design-Build-Test-Learn
DIYbio Do-It-Yourself Biology
DNA Deoxyribonucleic Acid
DOE U.S. Department of Energy
dsDNA Double-Stranded DNA
DSHEA Dietary Supplement Health and Education Act
ELSI Ethical, Legal, and Social Implications
EOP Executive Office of the President
EPA U.S. Environmental Protection Agency
ESA Endangered Species Act
EUP Experimental Use Permit
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2017. Preparing for Future Products of Biotechnology. Washington, DC: The National Academies Press. doi: 10.17226/24605.
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FACA Federal Advisory Committee Act
FBI Federal Bureau of Investigation
FDA U.S. Food and Drug Administration
FDCA Food, Drug, and Cosmetic Act
FIFRA Federal Insecticide, Fungicide, and Rodenticide Act
FONSI Finding of No Significant Impact
FTE Full-Time Employee
FWS U.S. Fish and Wildlife Service
GE Genetically Engineered
GRAS Generally Recognized as Safe
GRO Genomically Recoded Organism
IARPA Intelligence Advanced Research Projects Agency
IDE Investigational Device Exemption
iGEM International Genetically Engineered Machine
INAD Investigational New Animal Drug
IND Investigational New Drug
MAGE Multiplex Automated Genome Engineering
MCAN Microbial Commercial Activity Notice
NEPA National Environmental Policy Act
NGO Nongovernmental Organization
NIH National Institutes of Health
NIST National Institute of Standards and Technology
NMFS National Marine Fisheries Service
NOI Notice of Intent
NSF National Science Foundation
ORD Office of Research and Development
OSHA Occupational Safety and Health Administration
PIP Plant-Incorporated Protectant
PPA Plant Protection Act
PPDC Pesticide Program Dialogue Committee
rDNA Recombinant DNA
RFI Request for Information
RNA Ribonucleic Acid
RNAi RNA Interference
SAP Scientific Advisory Panel
ssDNA Single-Stranded DNA
TALEN Transcription Activator-Like Effector Nuclease
TSCA Toxic Substances Control Act
Page xvii Cite
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2017. Preparing for Future Products of Biotechnology. Washington, DC: The National Academies Press. doi: 10.17226/24605.
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USDA U.S. Department of Agriculture
USGS U.S. Geological Survey
ZFN Zinc Finger Nuclease
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Between 1973 and 2016, the ways to manipulate DNA to endow new characteristics in an organism (that is, biotechnology) have advanced, enabling the development of products that were not previously possible. What will the likely future products of biotechnology be over the next 5–10 years? What scientific capabilities, tools, and/or expertise may be needed by the regulatory agencies to ensure they make efficient and sound evaluations of the likely future products of biotechnology?

Preparing for Future Products of Biotechnology analyzes the future landscape of biotechnology products and seeks to inform forthcoming policy making. This report identifies potential new risks and frameworks for risk assessment and areas in which the risks or lack of risks relating to the products of biotechnology are well understood.

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