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
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International Standard Book Number-13: 978-0-309-45205-2
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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.
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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.
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.
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.
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.
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.
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
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.
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.
Contents
SELECT ACRONYMS AND ABBREVIATIONS
Information-Gathering Activities
2 EMERGING TRENDS AND PRODUCTS OF BIOTECHNOLOGY
Setting the Stage: Understanding the Key Drivers for Future Biotechnology Products
3 THE CURRENT BIOTECHNOLOGY REGULATORY SYSTEM
Overview of U.S. Regulatory System
4 UNDERSTANDING RISKS RELATED TO FUTURE BIOTECHNOLOGY PRODUCTS
Risks from Future Biotechnology Products: Similarities to the Past and Gaps Going Forward
Existing Federal Capabilities, Expertise, and Capacity
5 OPPORTUNITIES TO ENHANCE THE CAPABILITIES OF THE BIOTECHNOLOGY REGULATORY SYSTEM
Consistent, Efficient, and Effective Decision Making for Future Products of Biotechnology
Technical Toolbox and Capabilities for Risk Assessment and Regulatory Science
6 CONCLUSIONS AND RECOMMENDATIONS
Major Advances and New Types of Products
Current Risk-Analysis System and Agency Authorities
Future Products Under the Current Coordinated Framework
A BIOGRAPHICAL SKETCHES OF COMMITTEE MEMBERS
B AGENDAS OF INFORMATION-GATHERING SESSIONS
D CONGRESSIONALLY DEFINED PRODUCT CATEGORIES THAT THE U.S. FOOD AND DRUG ADMINISTRATION REGULATES
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 |
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 |
USDA | U.S. Department of Agriculture |
USGS | U.S. Geological Survey |
ZFN | Zinc Finger Nuclease |