Historically, the information in this publication has been advisory is nature even though legislation and regulation, in some circumstances, have overtaken it and made compliance with the guidance provided mandatory. We wish to emphasize that the 5th edition of the BMBL remains an advisory document recommending best practices for the safe conduct of work in biomedical and clinical laboratories from a biosafety perspective, and is not intended as a regulatory document though we recognize that it will be used that way by some. This edition of the BMBL includes additional sections, expanded sections on the principles and practices of biosafety and risk assessment; and revised agent summary statements and appendices. We worked to harmonize the recommendations included in this edition with guidance issued and regulations promulgated by other federal agencies.
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Voshicage He suggested that for the next edition, eedition editors consider telling BMBL users to work with their institution, which would have their own plans, in crafting emergency response plans for their labs. He said he thinks that adding links to ACIP 27 and other bodies that would provide this information would probably be the best way to address this comment. Page 15 Share Cite. Ellis asked if there might be a way to address this issue from a risk assessment standpoint.
Ellis said there were requests posted on the virtual town hall for additions to this section, i. He said verbiage that totally eliminates a 4tb or a desire for credentialing will do damage.
He suggested providing an overview and then making references to these websites. Hunt said another online workshop participant commented that the online version would be essential for addressing the inevitable and needed editino.
Laboratory Biosafety Manual, 3 rd Edition. Ellis said a discussion of how the HVAC system works would be pretty extensive but he thinks that lab personnel should understand how it works and know why they have to leave the lab when the HVAC system fails, and understand the basics of Bmbbl system re-start.
Hunt mentioned these general comments from the online workshop participants: She asked if the format should be retained or if the MSDS format should be used. Meechan asked Welch to clarify if he is editio that the level of certification required be edtiion or based on risk. Welch pointed out that DIY 38 Bio are becoming popular nowadays and for those who use these home kits, the closest thing they have to safety guidelines is the BMBL.
Wilson pointed out t4h there is already a variety of standards for eye protection out there, such. Emphasizing that droplets, not just aerosols, contaminate the environment and might also be part of the covert exposure that might be experienced. Hunt said most of the comments received via the virtual town hall were about specific things and the DOT 30 and IATA 31 regulations; she said a lot of people asked for inclusion of IATA regulations 44th the transport of biologicals. He said researchers are needed who will be funded to do this, and the only way this can be done is by having applied biosafety research programs.
Biosafety in Microbiological and Biomedical Laboratories BMBL 5th Edition Ellis said several edits were also suggested in this section and there were other comments, including one about increased stringency and justification that supports increasing level of precautions for BSL-1 agents. Ksiazek said there was a request to move the listing of all the arboviruses to an appendix.
Ksiazek pointed out that there are continuous cell lines in the ATCC 34 catalog that are at risk level 1, not 2; if the risk level carries over to the biosafety level and there is no contamination then these cell lines could be worked on at level 1. Page 3 Share Cite. Salerno said the concept of risk assessment, i.
Meechan said this is something that will not be done again. Bohn said she heard eeition DURC will be addressed in the recombinant section and in the select agent section and this worries her because DURC is not always a select agent or cross-recombinant. He noted that there were editon comments on this section that were posted on the virtual town hall; he said these will be passed on to the BMBL editors.
Ellis said the earlier discussion was about the agent summary statements serving the purpose of the BMBL well and that some of them need to be updated or information should be added to them. Biosafety in Microbiological and Biomedical Laboratories BMBL 5th Edition — CDC Ksiazek said it should be emphasized that a critical part of risk assessment is researching the topic, asking all the questions about risk, and looking at previous experience with the agent.
She suggested dovetailing those recommended positions with the BMBL guidelines on good governance. Salerno also commented that there seems to be a sense in the community that the BMBL is going to provide all the answers and all that needs to be done is follow what the BMBL says. He requested clarifying this concept better. Looking for other ways to read this? Accessed July 9, Ksiazek said there was a suggestion to cover insectaries in more detail. She added that the language can be worked on to broaden the intent because there are procedures that are more dangerous when done in a biosafety cabinet than outside of it.
The BMBL is not necessarily the appropriate place for this, but this could be mentioned in the select agent section, he added.
He asked if it would be appropriate to add an appendix for their specific needs or to indicate the differences, in terms of risk assessment, between a public health lab, a clinical lab, and a research lab. Wilson added that for each section of the BMBL there will be a lead a federal employee as well as subject matter experts, who will be recruited from all over the country and the world not federal employees. Hunt also mentioned the following comments that were posted on the virtual town hall: Accessed July 14, Wilson was then asked to clarify the intent of the BMBL—who is the audience?
On the issue of occupational health and review, Ksiazek said this is an institutional issue that is addressed when working with select agents, which requires medical surveillance. Ellis also mentioned a request to add information on recommended controls for cryostats and microtomes.
Ellis said he agrees with the approach of referencing websites where CFRs 32 and updated regulations are found rather than discussing them further in the BMBL. Jim Welch Elizabeth R. Page 7 Share Cite. Most 10 Related.
Biosafety in Microbiological and Biomedical Laboratories (BMBL) 5th Edition
Jucage He said he thinks that adding links to ACIP 27 and other bodies that would provide this information would probably be the best way to address this comment. 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. Or there might be a way to come up with another term, she added. Hunt said there was a comment from an online workshop participant about including guidance for generic unknown samples clinical and field samples in the BMBL.
BMBL 4TH EDITION PDF
She said providing definitions for types of protective eyewear would be somewhat counterproductive since there is already established guidance. According to Deborah Wilson NIH; one of the editors of the forthcoming BMBL 6th Editionthe BMBL 5th Edition was completed with input from over scientists, biosafety professionals, and subject matter experts—yet, despite the participation of numerous individuals in the previous BMBL revision, there were criticisms that the scientific and biomedical communities were not given the opportunity to provide input. Ellis went over the following major comments that were posted on the virtual town hall:. Adding an appendix on how to write a lab-specific manual or SOP would be helpful. He said the statement that there could be no reversal was taken to mean that there could be not one particle of smoke that could go a half inch out of the lab when exhaust systems were tested.