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.

Contents

• The National Academies of SCIENCES • ENGINEERING • MEDICINE
• 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
• Preface
• Acknowledgments
• Select Acronyms and Abbreviations
• Summary
  • THE COMMITTEE’S PROCESS
  • FUTURE BIOTECHNOLOGY PRODUCTS
  • THE BIOTECHNOLOGY REGULATORY PROCESS AND THE COORDINATED FRAMEWORK
  • UNDERSTANDING RISKS RELATED TO FUTURE BIOTECHNOLOGY PRODUCTS
  • OPPORTUNITIES FOR ENHANCEMENT OF THE BIOTECHNOLOGY REGULATORY SYSTEM
  • SUMMARY CONCLUSIONS
  • SUMMARY RECOMMENDATIONS
• 1. Introduction and Context
  • IMPETUS FOR THE STUDY
  • THE COMMITTEE AND ITS CHARGE
  • INFORMATION-GATHERING ACTIVITIES
  • ORGANIZATION OF THE REPORT
  • REPORT CONTEXT AND SCOPE
  • REFERENCES
• 2. Emerging Trends and Products of Biotechnology
  • SETTING THE STAGE: UNDERSTANDING THE KEY DRIVERS FOR FUTURE BIOTECHNOLOGY PRODUCTS
  • FUTURE BIOTECHNOLOGY PRODUCTS
  • SUMMARY AND CONCLUSIONS
  • REFERENCES
• 3. The Current Biotechnology Regulatory System
  • OVERVIEW OF U.S. REGULATORY SYSTEM
  • CONSUMER AND OCCUPATIONAL SAFETY
  • ENVIRONMENTAL PROTECTION
  • SUMMARY AND CONCLUSIONS
  • REFERENCES
• 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
  • SUMMARY AND CONCLUSIONS
  • REFERENCES
• 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
  • SUMMARY AND CONCLUSIONS
  • REFERENCES
• 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
  • OPPORTUNITIES FOR ENHANCEMENT
  • RECOMMENDATIONS
  • REFERENCES
• Glossary
• APPENDIXES
  • Appendix A. Biographical Sketches of Committee Members
  • Appendix B. Agendas of Information-Gathering Sessions
  • Appendix C. Requests for Information
  • Appendix D. Congressionally Defined Product Categories That the U.S. Food and Drug Administration Regulates

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.