This fourth edition of Biosafety in Microbiological and. Biomedical Laboratories editions of the BMBL, whose guidelines are now accepted as the international. This is not to say that the new BMBL will not require interpretations. This was clarified in the 4th edition by “Filtration and other treatments of. medical Laboratories (BMBL) (HHS et al., ) was pub- lished. Does our facility have to comply with the require- ments of this new edition? • The 4th edition of.
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Not a MyNAP member yet? Register for a free account to start saving and receiving special member only perks. According to Deborah Wilson NIH; one of the editors of the forthcoming BMBL 6th Editionthe BMBL 5th Edition was editipn 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.
She said for the next BMBL revision, a more open and transparent process will edirion employed, with input from users of the BMBL obtained via the virtual town hall meeting and workshop. Wilson said she is interested in hearing comments about a couple of areas, most importantly, she said she hopes the following questions will be addressed: He added that although it has been used internationally, as the basis of international guidance and regulations, it remains as a guidance document in the United States—it is not based on regulations and is centered on thoughtful risk assessment.
Meechan said all the comments received via the virtual town hall and the workshop will be looked at and considered and international partners will be consulted for harmonization. After the introductory remarks from Wilson and Meechan, the chair of the steering committee, Bob Ellis Colorado State University opened the floor for questions from the workshop participants those attending in person and those viewing the live webcast.
Robin Schoen National Academies of Sciences, Engineering, and Medicine asked if a bit more information could be provided about the revision process—to answer such questions as: 4tb is the team assembled? Does the document go through review? Will it be published in the Federal Register? Wilson said there is an executive BMBL steering committee, 2 composed of federal employees, and an editorial board that is also composed of federal employees from different agencies and mission partners.
She clarified that the BMBL is not a regulatory document and hence will not go through public comment and review. She noted that the BMBL has historically been performance ediiton and has served as the standard for edirion documents around the world but there have been suggestions to make it a regulatory document, hence, they BMBL editors want to know if users think it should be more prescriptive.
Wilson added that for each section of the BMBL there will be a lead a federal employee as well as subject matter t4h, who will be recruited from all over the country and the world not federal employees.
Tom Ksiazek University of Texas Medical Branch [UTMB]; member of the steering committee explained that the pressure to make the BMBL more prescriptive or more regulatory is due to the current regime of select agents; but not everyone handles select agents, so this document serves a larger audience.
Biosafety in Microbiological and Biomedical Laboratories (BMBL) 5th Edition
He said he thinks the BMBL should remain performance based. Jim Welch Elizabeth R. He suggested that the text be worded more strongly to encourage researchers to be aware of the risks. Wilson was then asked to clarify the intent of the BMBL—who is the audience? She explained that it was meant to provide performance-based guidance to biomedical and life sciences laboratories and clinical laboratories, although there have been other guidance documents for clinical labs.
She said it was meant for use in the academia, industry, and government but it has been used broadly, 4tu. Meechan noted that a number of institutions and agencies have taken general performance-based recommendations from the BMBL to craft more prescriptive guidance specifically suited to their institute or field, such as clinical laboratories. He asked if the BMBL should be expanded to have additional appendices for a series of greater or narrower fields and added that although this might not be to their best interest, the editors are open to discussing this.
Ellis mentioned that CDC published a document a few years ago about human clinical labs and veterinary diagnostic labs, particularly about the unique challenges with biosafety and containment of unknowns that come to the labs daily in large volumes.
He said this document set some baselines but did not go into the details that are contained in the BMBL; it is a good supplement but 4t BMBL remains the basis for most of the work that is being editlon. Debra Hunt Duke University; member of the steering committee said clinical labs have also developed their own standard through the CLSI, 4 which addresses clinical microbiology and gets into specific procedures and safety issues and is revised every now and then.
However, she noted, the BMBL still has the biggest impact on microbiology labs and clinical microbiology labs. He said the addition of Appendix D to the BMBL 5th Bmbk was the first time that agricultural biocontainment was addressed in the BMBL; Appendix D will also be in the 6th Edition because the USDA guidance on agricultural biocontainment will not be done by the time this edition comes out the guidance will take 5 to 6 years to finish.
For example, when the recent Ebola outbreak occurred, not having the proper guidance became a problem, he added.
The comment was about how updates on agent risk level can be expediently shared with the public, without waiting until the next edition of BMBL is released. He explained that if research has shown that it is perfectly safe to work with an agent at BSL 6 -2 instead of BSL-3, then the risk group is lowered from 3 to 2 but some entities will not recognize this change unless it is published in the BMBL.
Wilson said this is an issue that has been discussed before and still has not been resolved. She said the BMBL has to be more of a living document, posted in an electronic format that is easier to use and can be readily updated as science evolves and as public and global health situations change. Ksiazek said having the BMBL 5th Edition available only in digital form for a couple of years no printed copies was not ideal from the viewpoint of some users; it cannot be too much of a living document.
Meechan said this is something that will not be done again. He said a process that parallels that for select agents probably makes the most sense. Patricia Delarosa NIH said she thinks the greatest area of confusion is with the risk assessment, across the board, both in the public health and lab sector but more so in the public health sector.
Citing the incident where a nurse was infected with Ebola as an example the hospital PPE 8 was not adaptedshe asked if there could be something added in the risk assessment section that gives BMBL users a better idea about increasing or decreasing BSL to address certain risks. Ksiazek said risk assessment is a formal science but experience counts as well; sometimes one is presented with a new situation for which there is no experience—and a practical approach is needed to deal with it, not just assign this to BSL Edltion said that hospitals are different from labs, the BMBL cannot advocate for humans to be put in level 4 containment because hospitals are not eition to do this.
Delarosa said it would be very helpful if the BMBL could better communicate risk to people, as this is an important component of risk assessment. Ellis went over the following major comments that wdition posted on the virtual town hall:. 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.
He suggested that for the next edition, the editors consider telling BMBL users to work with their institution, which would have their own plans, in crafting emergency response plans for editino labs.
Ellis said a discussion of these fairly new topics perhaps in the introduction part seems. A biosafety ediion is a designation based on a composite of the design features, construction, containment facilities, equipment, practices and operational procedures required for working with wdition from various risk groups WHO. Laboratory Biosafety Manual, 3 rd Edition. Available online at http: Accessed July 14, References could be made to the actual documents published by agencies that handle concerns particular to these topics, he added.
Should there be an easy-to-understand flow chart for certain things like how to clean up a spill? Add a section on the importance of hiring credentialed biosafety professionals. Ellis said the BMBL is currently geared more towards providing guidance to PIs 12 and lab directors on how to safely conduct research but biosafety professionals should also be involved in making decisions on procedures.
Ksiazek said the approval of the use of an organism or a protocol is done by the IBC 13 in some institutions; the IBC also reviews notices of use and notices of intent, however, sometimes these are just reviewed by a safety officer or by the PI. This process is somewhat nebulous and ought to be clarified, he added.
Editon should be a section on the importance of developing a strong safety culture. Ellis suggested that instead of a stand-alone chapter, this could just be added to the introduction. Ellis said there was also a comment about the recently released GAO 14 report on ecition labs, particularly the six elements in the GAO report and ways of having bio-risk management standards.
He said he thinks these are important issues but is not sure where they should be addressed and how much detail should be included in the BMBL. The BMBL should have an online version that can be updated as new information becomes available. Ellis commented that as changes arise, how can the BMBL be updated without having to rewrite and republish the full document? There needs to be a mechanism for relaying changes to BMBL users in a timely manner, he said.
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Consider rearrangement of chapters. Ellis said most BMBL users are now accustomed to how the chapters are arranged; if they are rearranged then users have to get used to a different arrangement.
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. Welch commented that business owners are required to have certified public accountants CPAs perform audits; similarly, there are certain research activities that require credentialed biosafety professionals.
He said it is an essential element of bio-risk management to have credentials that indicate a certain level of expertise.
Meechan asked Welch to clarify if he is suggesting that the level of certification required be tiered or based on risk. Welch said there are labs, because of the type of research they perform, that do not necessarily require certified biosafety professionals.
He said verbiage that totally eliminates a need or a desire for credentialing will do damage. However, she said she also believes in having certified biosafety professionals. Kristie Yeakle DAIG 15 mentioned the difficulty of getting the training and still being expected to do their jobs. Hunt said the need for biosafety professionals should be emphasized to elevate the status of this professional category.
Hunt clarified that the steering committee is not giving recommendations; its members are just making comments as BMBL users. Hunt said developing a strong safety culture could also be an institutional issue. She suggested dovetailing those recommended positions with the BMBL guidelines on good governance.
Ksiazek said applied biosafety research is lacking and safety officers use anecdotal evidence because of lack of data. He said there should be a way to hire people to do experiments that address issues that lab workers have to deal with.
He noted that some experiments have been done in the 60s and 70s and very little has been published recently.
However, he wondered if the BMBL is the right place for a discussion of this issue but it needs to be raised. Meechan agreed that the BMBL is not the right venue. Wilson said there are several ongoing federal activities that would have an impact on the BMBL.
Lawrence said there are federal activities under the offices of the White House, the Office of Science and Technology, and the National Security Council.
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 added that they have taken concrete actions to implement measures to enhance biosafety and biosecurity and address some of the issues being discussed today and that they will be engaging stakeholders in their activities.
As a follow up on the issue on the lack of applied biosafety research, Kozlovac said he thinks biosafety professionals will not be the ones who would actually conduct the research.
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. He mentioned that he made this point in the Trans-Federal Task Force report and there are working groups on this that he and Theresa Lawrence are leading.
The BMBL should remain a guidance document, but much debate remains about the basis of its implementation. Accessed June 13, Accessed June 14, The discussion of risk assessment was a little dismissive.
Ellis said the comment included a suggestion to add a small guide to tools for risk reduction, hierarchy of controls, risk assessment methods, and risk reduction methods and metrics to the BMBL.
Biosafety in Microbiological and Biomedical Laboratories (BMBL) 5th Edition – CDC
Hunt noted that not too many comments were received on Section I. She shared the following comments that were posted on the virtual town hall:. Providing guidance on dual-use research 4tu concern and gain of function.
Updating laboratory acquired infections LAI data.