Preparing for Future Products of Biotechnology PDF
Preview Preparing for Future Products of Biotechnology
THE NATIONAL ACADEMIES PRESS This PDF is available at http://www.nap.edu/24605 SHARE Ū ſ Ŷ Þ Preparing for Future Products of Biotechnology DETAILS 214 pages | 6 x 9 | PAPERBACK ISBN 978-0-309-45205-2 | DOI: 10.17226/24605 CONTRIBUTORS GET THIS BOOK 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 FIND RELATED TITLES on Chemical Sciences and Technology; Division on Earth and Life Sciences; National Academies of Sciences, Engineering, and Medicine Visit the National Academies Press at NAP.edu and login or register to get: – Access to free PDF downloads of thousands of scientific reports – 10% off the price of print titles – Email or social media notifications of new titles related to your interests – Special offers and discounts Distribution, posting, or copying of this PDF is strictly prohibited without written permission of the National Academies Press. (Request Permission) Unless otherwise indicated, all materials in this PDF are copyrighted by the National Academy of Sciences. Copyright © National Academy of Sciences. All rights reserved. Preparing for Future Products of Biotechnology PREPUBLICATION COPY 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 Copyright © National Academy of Sciences. All rights reserved. Preparing for Future Products of Biotechnology 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 Agen- cy. Any opinions, findings, conclusions, or recommendations expressed in this publication do not neces- sarily 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: 10.17226/24605 Additional copies of this publication are available for sale 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 2017 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. 2017. Preparing for Future Products of Biotechnology. Washington, DC: The National Academies Press. doi: 10.17226/24605. Copyright © National Academy of Sciences. All rights reserved. Preparing for Future Products of Biotechnology The National Academy of Sciences was established in 1863 by an Act of Congress, signed by Presi- dent Lincoln, as a private, nongovernmental institution to advise the nation on issues related to sci- ence 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 presi- dent. The National Academy of Medicine (formerly the Institute of Medicine) was established in 1970 un- der the charter of the National Academy of Sciences to advise the nation on medical and health is- sues. 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 Med- icine to provide independent, objective analysis and advice to the nation and conduct other activi- ties to solve complex problems and inform public policy decisions. The National Academies also en- courage 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. Copyright © National Academy of Sciences. All rights reserved. Preparing for Future Products of Biotechnology 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 Na- tional Academies of Sciences, Engineering, and Medicine. Proceedings chronicle the presentations and discussions at a workshop, symposium, or other con- vening 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 Acade- mies of Sciences, Engineering, and Medicine. For information about other products and activities of the National Academies, please visit national academies.org/whatwedo. Copyright © National Academy of Sciences. All rights reserved. Preparing for Future Products of Biotechnology COMMITTEE ON FUTURE BIOTECHNOLOGY PRODUCTS AND OPPORTUNITIES TO ENHANCE CAPABILITIES OF THE BIOTECHNOLOGY REGULATORY SYSTEM Chair 1 RICHARD M. MURRAY, NAE , California Institute of Technology, Pasadena Members 2 RICHARD AMASINO, NAS , 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 2 RICHARD A. JOHNSON, NAS , Global Helix LLC, Washington, DC (resigned August 2016) MARTHA 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. Prepublication Copy v Copyright © National Academy of Sciences. All rights reserved. Preparing for Future Products of Biotechnology BOARD ON LIFE SCIENCES Chair JAMES P. COLLINS, Arizona State University, Tempe Members 1 ENRIQUETA C. BOND, NAM , Burroughs Wellcome Fund, Marshall, VA 2 ROGER D. CONE, NAS , University of Michigan, Ann Arbor NANCY D. CONNELL, Rutgers New Jersey Medical School, Newark 2 JOSEPH R. ECKER, NAS , Salk Institute for Biological Studies, LaJolla, California SARAH C. R. ELGIN, Washington University, St. Louis, MO 3 LINDA G. GRIFFITH, NAE , Massachusetts Institute of Technology, Cambridge ELIZABETH HEITMAN, University of Texas Southwestern Medical Center, Dallas RICHARD A. JOHNSON, Global Helix LLC, Washington, DC 2 JUDITH KIMBLE, NAS , 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 1 CLAIRE POMEROY, NAM , The Albert and Mary Lasker Foundation, New York, NY 2 MARY E. POWER, NAS , 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. vi Prepublication Copy Copyright © National Academy of Sciences. All rights reserved. Preparing for Future Products of Biotechnology 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, Nestle Purina PetCare, St. Louis, MO GEBISA EJETA, Purdue University, West Lafayette, IN 1 ROBERT B. GOLDBERG, NAS , University of California, Los Angeles 1 FRED GOULD, NAS , 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 2 JIM E. RIVIERE, NAM , 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. Prepublication Copy vii Copyright © National Academy of Sciences. All rights reserved. Preparing for Future Products of Biotechnology BOARD ON CHEMICAL SCIENCES AND TECHNOLOGY Co-Chairs DAVID BEM, PPG Industries, Pittsburgh, PA 1 JOAN BRENNECKE, NAE , Notre Dame University, South Bend, IN Members HÉCTOR D. ABRUÑA, Cornell University, Ithaca, NY JOEL C. BARRISH, Achillion Pharmaceuticals, New Haven, CT 1 MARK BARTEAU, NAE , 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 2 RICHARD EISENBERG, NAS , University of Rochester, New York 2 SAMUEL H. GELLMAN, NAS , University of Wisconsin–Madison 2 SHARON C. GLOTZER, NAS , University of Michigan, Ann Arbor MIRIAM E. JOHN, Sandia National Laboratories (Retired), Livermore, CA 1 FRANCES S. LIGLER, NAE , 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 2 PETER J. ROSSKY, NAS , Rice University, Houston, TX 2 TIMOTHY SWAGER, NAS , 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. vi Prepublication Copy Copyright © National Academy of Sciences. All rights reserved. Preparing for Future Products of Biotechnology Preface The Coordinated Framework for the Regulation of Biotechnology is the U.S. government’s mecha- nism 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 future 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 un- foreseen) advances of the past 5–10 years, it is clear that making accurate predictions of what will be pos- sible 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 accessible to a broader range of actors. 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 com- peting 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 commit- tee reached consensus on conclusions and recommendations that are based on extensive information gath- ering, 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 scienc- es 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 discus- sions that helped shaped 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 Biotechnology Regulatory System Prepublication Copy ix Copyright © National Academy of Sciences. All rights reserved.
The list of books you might like
