Soliciting Stakeholder Input for a Revision of Biosafety in Microbiological and Biomedical Laboratories (BMBL) Proceedings of a Workshop (2016) / Chapter Skim
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WORKSHOP DISCUSSION
WORKSHOP DISCUSSION
Pages 2-19
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He said he thinks the BMBL should remain performance based. 1 The virtual town hall commenters were not asked to specifically address these questions.
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For example, when the recent Ebola outbreak occurred, not having the proper guidance became a problem, he added. Ellis shared a comment on Section VIII that was received via the virtual town hall.
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General Comments on the BMBL Ellis went over the following major comments that were posted on the virtual town hall: Appendix F addressed emergency responses, which appears in the BMBL 4th Edition, but it is not found in the BMBL 5th Edition. Ellis said that while he agrees that each lab should have appropriate emergency response plans, it would be difficult to lay out specific emergency response plans in the BMBL -- because different labs deal with different types of pathogens with different emergency response requirements.
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Harbourt said he appreciates the need to hire credentialed biosafety professionals when possible but care should be taken so as not to close the avenue through which new biosafety professionals enter the profession, i.e., by initially holding entry-level positions to gain experience to eventually obtain credentials. Welch commented that business owners are required to have certified public accountants (CPAs)
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She mentioned that a memo requesting that agencies develop an implementation plan to address specific activities for strengthening biosafety and biosecurity in the United States was released last October. She also said an implementation plan that addresses the culture of responsibility and biosafety/biosecurity governance18 was developed and two reports were issued, one written by the Federal Experts Security Advisory Panel, which contains recommendations to strengthen biosafety and biosecurity and one written by the Fast Track Action Committee on Select Agent Regulations, which focuses on select agent regulations.
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Shea clarified that determining the root cause would be more for writing modern and accurate risk assessments. Comments on BMBL Section II – Biological Risk Assessment Hunt said the following suggestions were posted on the virtual town hall meeting: Adding a little bit more risk assessment information on toxins.
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Comments on BMBL Section IV – BSL Criteria Ellis said aside from requests for clarification, there were comments posted on the virtual town hall about the following topics: Eye protection with or without contact lenses. Ellis said perhaps it should be more clearly stated that all people must have some sort of eye protection.
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Several workshop participants, including one online workshop participant said redundancy is helpful, do not consolidate the information. Ellis also mentioned the following comments from the online workshop participants: If the intent of the BMBL is not to limit the applicability of its guidance to research labs, then it will help to have a remark to that effect.
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. Before closing the discussion of Section IV comments, Hunt mentioned the following comments from the online workshop participants: Eye protection and determination about face shields or respirators should be based on risk assessment -- this is not an absolute requirement as written in the BMBL.
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He noted that there were other comments on this section that were posted on the virtual town hall; he said these will be passed on to the BMBL editors. Comments on BMBL Section VI – Principles of Laboratory Biosecurity Ksiazek discussed two comments in this section that were posted on the virtual town hall.
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Ksiazek asked what can be done to streamline the process; if there should be a reference in the BMBL to the online approved list of select agents, which gets updated more often than the BMBL. Ksiazek said there was a comment posted on the virtual town hall that mentioned a clinical report published in January this year about four confirmed cases of HIV infections in nonclinical technicians; he said the agent summary statement should be updated.
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Comments on BMBL Appendix A – Primary Containment for Biohazards Ellis said there were several comments posted on the virtual town hall that pertain to this appendix and these will be handed over to the BMBL editors. He noted that there is one really long and valuable comment that he thinks should be looked at by the editors; he suggested that the editors work with the person who submitted this comment to ensure accuracy throughout this appendix.
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He also mentioned the following comments from the virtual town hall: Include some standardized approach for inactivation. Ellis said there have been failures and questions about inactivation so perhaps a format for developing inactivation procedures and validation methods for these procedures would be a good addition.
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Comments on BMBL Appendix C – Transportation of Infectious Substances Hunt said most of the comments received via the virtual town hall were about specific things and the DOT30 and IATA31 regulations; she said a lot of people asked for inclusion of IATA regulations on the transport of biologicals. Ellis said he believes that because changes in regulations happen every year it would be better to refer to the IATA and DOT websites at the very beginning of this section and make it clear that BMBL users should access those websites to get the most up-to-date information.
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Comments on BMBL Appendix J – NIH Oversight of Research Involving Recombinant Biosafety Issues Hunt said one comment on the virtual town hall was about the inclusion of "Synthetic Nucleic Acid Molecules" to the appendix title and to update the definition on page 394; she said this commenter also pointed out the omission that Section III-F experiments are exempt from IBC review and approval. She mentioned that there was a lengthy comment posted on the virtual town hall about dealing with the new realities of dangerous research, specifically the addition of a nongovernment committee of experts to the parties that review laboratory-created potential pan 33 Biosafety cabinet.
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Ellis said he thinks the document only covers dayto-day lab orientation and management and other topics that are not covered in the BMBL from a clinical and diagnostic lab standpoint. Hunt said one other comment they received was that the bacterial agent summary statements include how specific organisms should be handled in the clinical lab versus the research lab but this is not the case with the viral agent summary statements -- so information should be added to the viral agent summary statements.
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Comments on BMBL Appendix L – Acronyms There were no comments on this appendix. Revising the BMBL: Final Thoughts After the discussion of the BMBL sections and appendices, Wilson asked the workshop participants to address the following issues that she mentioned at the beginning of the workshop: Should the BMBL remain performance based or should it be prescriptive?
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Hunt said another online workshop participant commented that the online version would be essential for addressing the inevitable and needed amendments. Are the current agent summary statements adequate or should the content be changed?
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