Soliciting Stakeholder Input for a
Revision of Biosafety in Microbiological
and Biomedical Laboratories (BMBL)
Proceedings of a Workshop
Camilla Y. Ables, Rapporteur
Board on Agriculture and Natural Resources
Division on Earth and Life Studies
THE NATIONAL ACADEMIES PRESS
Washington, DC
www.nap.edu
THE NATIONAL ACADEMIES PRESS 500 Fifth Street, NW Washington, DC 20001
This activity was supported by Grant No. HHSN263201200074I from HHS and NIH. 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.
Digital Object Identifier: 10.17226/23585
Copyright 2016 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. 2016. Soliciting Stakeholder Input for a Revision of Biosafety in Microbiological and Biomedical Laboratories (BMBL): Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/23585.
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 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.
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 are not necessarily 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 Academies, please visit nationalacademies.org/whatwedo.
COMMITTEE ON SOLICITING STAKEHOLDER INPUT FOR A REVISION OF “BIOSAFETY IN MICROBIOLOGICAL AND BIOMEDICAL LABORATORIES”: A WORKSHOP AND VIRTUAL TOWN HALL1
Members
ROBERT ELLIS (Chair), Colorado State University
DEBRA HUNT, Duke University
TOM KSIAZEK, University of Texas Medical Branch
Study Staff
CAMILLA YANDOC ABLES, Study Director
JENNA BRISCOE, Senior Program Assistant
ROBIN A. SCHOEN, Director, Board on Agriculture and Natural Resources
___________________
1The committee members were not involved in the writing of the proceedings of the workshop.
BOARD ON AGRICULTURE AND NATURAL RESOURCES
Members
CHARLES W. RICE (Chair), Kansas State University, Manhattan
HAROLD L. BERGMAN, University of Wyoming, Laramie
SUSAN CAPALBO, Oregon State University, Corvallis
GAIL CZARNECKI-MAULDEN, Nestle Purina PetCare, St. Louis, Missouri
RICHARD A. DIXON, NAS,1 University of North Texas, Denton
GEBISA EJETA, Purdue University, West Lafayette, Indiana
ROBERT B. GOLDBERG, NAS,1 University of California, Los Angeles
FRED GOULD, NAS,1 North Carolina State University, Raleigh
GENE HUGOSON, University of Minnesota, St. Paul
JAMES W. JONES, NAE,2 University of Florida, Gainesville
STEPHEN S. KELLEY, North Carolina State University, Raleigh
JIM E. RIVIERE, NAM,3 Kansas State University, Manhattan
Staff
ROBIN A. SCHOEN, Director
CAMILLA YANDOC ABLES, Program Officer
JENNA BRISCOE, Senior Program Assistant
KARA N. LANEY, Program Officer
PEGGY TSAI YIH, Senior Program Officer
___________________
1National Academy of Sciences.
2National Academy of Engineering.
3National Academy of Medicine.
ACKNOWLEDGEMENT OF REVIEWERS
This proceedings of a workshop 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 proceedings as sound as possible and to ensure that the proceedings meets institutional standards for objectivity, evidence, and responsiveness to the study charge. We wish to thank the following individuals for their review of this proceedings:
Kenneth Berns, University of Florida (emeritus)
Sherry Bohn, University of Maryland
Maureen Ellis, International Federation of Biosafety Associations
Robert Ellis, Colorado State University
Although the reviewers listed above have provided many constructive comments and suggestions, they were not asked to endorse, nor did they see, the final draft of the proceedings before its release. The review of the proceedings was overseen by Ron Atlas of the University of Louisville, he was responsible for making certain that an independent examination of the proceedings was carried out in accordance with institutional procedures and that all review comments were carefully considered. Responsibility for the final content of the proceedings of a workshop rests entirely with the author and the National Academies of Sciences, Engineering, and Medicine.
This page intentionally left blank.
CONTENTS
Soliciting Stakeholder Input – Opening Remarks by NIH and CDC
The BMBL as a Guidance Document
Comments on BMBL Section I – Introduction
Comments on BMBL Section II – Biological Risk Assessment
Comments on BMBL Section III – Principles of Biosafety
Comments on BMBL Section IV – BSL Criteria
Comments on BMBL Section V – Vertebrate Animal BSL Criteria
Comments on BMBL Section VI – Principles of Laboratory Biosecurity
Comments on BMBL Section VII – Occupational Health and Immunoprophylaxis
Comments on BMBL Section VIII – Agent Summary Statements
Comments on BMBL Appendix A – Primary Containment for Biohazards
Comments on BMBL Appendix B – Decontamination and Disinfection
Comments on BMBL Appendix C – Transportation of Infectious Substances
Comments on BMBL Appendix D – Agricultural Pathogen Biosafety
Comments on BMBL Appendix E – Arthropod Containment Guidelines
Comments on BMBL Appendix F – Select Agents and Toxins
Comments on BMBL Appendix G – Integrated Pest Management
Comments on BMBL Appendix H – Working with Human, NHP and Other Mammalian Cells and Tissues
Comments on BMBL Appendix I – Toxins of Biological Origin
Comments on BMBL Appendix J – NIH Oversight of Research Involving Recombinant Biosafety Issues
Comments on BMBL Appendix K – Resources
Comments on BMBL Appendix L – Acronyms
Revising the BMBL: Final Thoughts
APPENDIXES
