Proceedings of a Workshop Series

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

This activity was supported by a contract between the National Academy of Sciences and the U.S. Government. 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: 978-0-309-71904-9
Digital Object Identifier: https://doi.org/10.17226/27767

This publication is available from the National Academies Press, 500 Fifth Street, NW, Keck 360, Washington, DC 20001; (800) 624-6242; https://nap.nationalacademies.org.

The manufacturer’s authorized representative in the European Union for product safety is Authorised Rep Compliance Ltd., Ground Floor, 71 Lower Baggot Street, Dublin D02 P593 Ireland; www.arccompliance.com.

Copyright 2026 by the National Academy of Sciences. National Academies of Sciences, Engineering, and Medicine and National Academies Press and the graphical logos for each are all trademarks of the National Academy of Sciences. All rights reserved.

Printed in the United States of America.

Suggested citation: National Academies of Sciences, Engineering, and Medicine. 2026. Biological Threats in the Age of Emerging Biotechnology: Proceedings of a Workshop Series. Washington, DC: National Academies Press. https://doi.org/10.17226/27767.

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. Tsu-Jae Liu 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.nationalacademies.org.

Consensus Study Reports published by the National Academies of Sciences, Engineering, and Medicine document the evidence-based consensus on the study’s statement of task by an authoring committee of experts. Reports typically include findings, conclusions, and recommendations based on information gathered by the committee and the committee’s deliberations. Each report has been subjected to a rigorous and independent peer-review process and it represents the position of the National Academies on the statement of task.

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

Rapid Expert Consultations published by the National Academies of Sciences, Engineering, and Medicine are authored by subject-matter experts on narrowly focused topics that can be supported by a body of evidence. The discussions contained in rapid expert consultations are considered those of the authors and do not contain policy recommendations. Rapid expert consultations are reviewed by the institution before release.

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

PLANNING COMMITTEE FOR BIOLOGICAL THREATS IN THE AGE OF EMERGING BIOTECHNOLOGY: A WORKSHOP SERIES

MARIA ESPONA (Co-Chair), Argentina Information Quality

SURYESH NAMDEO (Co-Chair), India Institute of Science, Bangalore (until March 2025)

NIDHI ADLAKHA, Regional Centre for Biotechnology, Faridabad

MAYRA AMENEIROS, International Biosecurity and Biosafety Initiative for Science

LUCIANA BALBOA, Institute for Biomedical Research on Retroviruses and AIDS (INBIRS), University of Buenos Aires - CONICET

MÓNICA LIZETH CHÁVEZ GONZÁLEZ, Autonomous University of Coahuila, Mexico

ROCIO ALEJANDRA CHAVEZ-SANTOSCOY, Technologico de Monterrey, Campus Monterrey

MARIA MELINA FLOREZ-CUADROS, Universidad Peruana Cayetano Heredia

URIEL ALEJANDRO LÓPEZ LEMUS, Gene SL

LARISA RUDENKO, BioPolicy Solutions LLC

PAMELA A. SILVER, Harvard Medical School and Wyss Institute

Staff

SARAH JUCKETT, Senior Program Officer

KAVITA BERGER, Director, Life Sciences and Biotechnology Program Area

CHRISTL SAUNDERS, Program Coordinator (until August 2025)

JESSICA DE MOUY, Research Associate

DASIA MCKOY, Senior Program Assistant (until July 2025)

MARIAH WAUL, Senior Program Assistant (as of July 2025)

CYNTHIA GETNER, Senior Finance Business Partner

Rapporteur

CAROL BERKOWER, Independent Consultant

This page intentionally left blank.

Reviewers

This Proceedings of a Workshop Series 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 proceedings as sound as possible and to ensure that it meets the institutional standards for quality, objectivity, evidence, and responsiveness to the charge. The review comments and draft manuscript remain confidential to protect the integrity of the process.

We thank the following individuals for their review of this proceedings:

Although the reviewers listed above provided many constructive comments and suggestions, they were not asked to endorse the content of the proceedings nor did they see the final draft before its release. The review of this proceedings was overseen by Michael Ladisch, NAE, Purdue University. He was responsible for making certain that an independent examination of this proceedings was carried out in accordance with standards of the National Academies and that all review comments were carefully considered. Responsibility for the final content rests entirely with the rapporteur and the National Academies.

This page intentionally left blank.

Acknowledgments

The Biological Threats in the Age of Emerging Biotechnology planning committee and National Academies staff would like to thank all speakers who participated in the workshop sessions and provided indispensable expertise and background on the common and unique landscapes of conducting science in Mexico, Peru, Argentina, and India tying into our charge (see Box 1-1).

We thank Emmanuelle Lievina A. Tuerlings and Luis Ochoa Carrera for their contributions to our first workshop. We thank Luis Herrera-Estrella and Lena Gálvez Ranilla for their contributions to our third workshop. We thank Mayra Ameneiros, Tessa Alexanian, Suryesh Namdeo, Ricardo Chavez, and Becky Mackelprang for their contributions to our third workshop; and staff would like to extend thanks to the committee members who moderated and presented during all four workshops. We thank Carol Berkower for excellent and accurate writing of all workshops. Finally, we also thank the LEXT Translations team for excellent live interpretation in Spanish and English languages. We thank Ourania Kosti and Sophia Nordt for their help with committee formation and project promotion.

The National Academies staff thanks the committee (see Appendix C) for their participation in this series of workshops. The committee thanks the National Academies staff for their support in ensuring the successful completion and publication of this proceedings summarizing the discussions from December 2024 through September 2025.

This page intentionally left blank.

Contents

1 INTRODUCTION

Project Statement of Task and Planning Committee Approach

Dual-Use Concepts Expand Beyond Pathogens and Toxins

Framework Areas to Consider

Challenges of identifying Risks in Emerging Technologies

2 BIOTECHNOLOGY-BASED CASE STUDIES

Human Health Multi-Omics

Multi-Omic Analysis for Crop Improvement

DNA Synthesis

3 CURRENT FRAMEWORKS AND POLICY CHALLENGES

Review of Existing Frameworks and Guidance

Country-Specific Landscapes

4 CHALLENGES AND OPPORTUNITIES

A Viewpoint of Benefits

Data Management

Policy Development, Engagement, And Entrepreneurship

Final Workshop Remarks

REFERENCES

APPENDIXES

A MEETING AGENDAS

Workshop #1: Frameworks

Workshop #2: The Use of Multi-Omic Data to Affect Human Health

Workshop #3: The Use of Multi-Omic Data to Affect Crop Improvement

Workshop #4: DNA Synthesis Screening

B PLANNING COMMITTEE DEVELOPED SCENARIOS

Planning Committee Developed Scenario Discussion Questions

The Use of Multi-Omic Data to Affect Human Health (In Silico Modeling & Bioinformatics Approaches)

The Use of Multi-Omic Data to Affect Crop Improvement (In Silico Modeling & Bioinformatics Approaches)

DNA Synthesis

C COMMITTEE MEMBER AND SPEAKER BIOGRAPHIES

Boxes, Figures, and Tables

BOXES

1-1 Statement of Task

1-2 Definitions Used by the Planning Committee

2-1 EBRC Best Practices for Nucleic Acid Synthesis Screening

FIGURES

2-1 Breeding Strategies for Improving Orphan Crops

2-2 Peruvian Andean Maize Cabanita Kernels at Three Maturity Stages

2-3 Bioeconomy Applications Including the Design, Build, Test, Learn Cycle

2-4 Engineering Biology Research Consortium Sequence Concern vs. Customer Concerns Risk Matrix for Nucleic Acid Synthesis Orders

3-1 International Frameworks for Biosafety in the Life Sciences

3-2 Reviewing Risks and Benefits Assessments (Journal Articles and Reviews)

3-3 Descriptions and Articles on the Bioeconomy (International)

3-4 India: Policy, Guidance, and Framework Documents

3-5 Mexico*, Peru*, Argentina and Latin America: Bioeconomy and Biotechnology Analyses

3-6 Mexico, Peru, Argentina and Latin America: Additional Resources

3-7 International Frameworks Relevant to Synthetic Nucleic Acid Regulation

TABLES

3-1 Import Screening Process Steps for Mexico, Argentina and Peru

3-2 Export Screening Process Steps for Mexico, Argentina and Peru

Acronyms and Abbreviations