Soliciting Stakeholder Input for a Revision of Biosafety in Microbiological and Biomedical Laboratories (BMBL)

INTRODUCTION

Since its publication by the National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC) in 1984, Biosafety in Microbiological and Biomedical Laboratories (BMBL) has become the cornerstone of the practice of biosafety in the United States and in many countries around the world. The BMBL has been revised periodically over the past three decades to refine the guidance it provides based on new knowledge and experiences—allowing it to remain a relevant, valuable, and authoritative reference for the microbiological and biomedical community.

Seven years after the release of the BMBL 5th Edition, NIH and CDC are considering a revision based on the comments of a broader set of stakeholders. At the request of NIH, the National Academies of Sciences, Engineering and Medicine conducted a virtual town hall meeting from 4 April to 20 May 2016 to allow BMBL users to share their thoughts on the BMBL in general and its individual sections and appendices. Specifically, users were asked to indicate what information they think should be added, revised, or deleted. Major themes from the virtual town hall meeting were further discussed in a workshop held on 12 May 2016 in Washington, DC. The workshop was also webcast live. A steering committee was appointed by the National Academies of Sciences, Engineering, and Medicine to lead and moderate the workshop discussion. This document encapsulates the discussion of the major comments on the BMBL that were posted on the virtual town hall (http://nas-sites.org/bmbl/) prior to 12 May 2016 and the various BMBL comments and issues related to biosafety that were raised during the workshop by participants who attended the meeting in Washington DC and those who listened to the live webcast.

A total of 257 comments were posted on the virtual town hall from 4 April to 20 May. The majority of the comments pertained to Section VIII (112) and there were 41 general comments. The total number of comments for the rest of the BMBL sections and appendices are as follows: Section I (4); Section II (15); Section III (6); Section IV (22); Section V (10); Section VI (3); Section VII (3); Appendix A (11); Appendix B (9); Appendix C (4); Appendix D (2); Appendix E (4); Appendix F (3); Appendix H (1); Appendix I (2); Appendix J (4) and Appendix K (1). There were no comments on Appendix G and L on the virtual town hall. The comments on the virtual town hall were from individuals affiliated with the following type of institutions: university lab (36); animal facility (11); government lab (23); public health lab (120); private lab (27); clinical lab (3); and other (37). A total of 71 miscellaneous comments were sent in by the online workshop participants. Not all the comments from the virtual town hall and the online workshop participants were discussed during the workshop, only the major comments; these are presented in bold and italic font in this document. Comments posted on the virtual town hall after the workshop are not included in this workshop summary but they may be viewed at the virtual town hall website. The workshop had a total of 115 attendees, 22 attended in person and 95 viewed the webcast. A copy of all comments posted on the virtual town hall and those that were sent in during the workshop have been provided to NIH and CDC.

This document was prepared by Camilla Y. Ables as a factual summary of the discussion that occurred during the workshop. The role of the steering committee was to review the comments posted on the virtual town hall prior to the workshop, share the major comments from the online workshop participants, and lead/moderate the discussion of these comments as well as the issues brought up by those who attended the workshop in person. The statements contained herein are those of the author and the virtual town hall meeting and workshop participants and do not necessarily represent the views of all users of the BMBL who may or may not have posted comments on the virtual town hall, the workshop participants, the steering committee, and the National Academies of Sciences, Engineering, and Medicine.