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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However, he wondered if the BMBL is the right place for a discussion of this issue but it needs to be raised. BSL-1 signage is helpful to define when biological materials can be used in a lab, to indicate that a sink is present, and when wdition lab is really only for nonviable materials and chemicals.
Salerno said the concept of risk assessment, i.
Biosafety in Microbiological and Biomedical Laboratories (BMBL) 5th Edition
Accessed June 13, Bohn said if these materials are put under BSL-2, then this appendix might not be needed; clearly explaining why these materials need containment and 4fh to be worked on at BSL-2 would be important. Wilson thinks the BMBL editors should look at the recommendation to work on infected animals only in primary containment and refer to the use of local exhaust ventilation devices or slot hoods.
Hunt said an online workshop participant commented that working with LPS 35 is a challenge.
He noted that most of the other comments posted on the virtual town hall are for the subject matter experts, he said the group that will review this section should take a look at Francisella tularensis.
She shared the following comments that were posted on the virtual town hall:. If there is a risk to people who are never or rarely at those BSL-1 labs then this is the reason why signage is needed, he added.
Wilson explained that the errors could be due to the redundancy in presenting information, which entailed a lot of copying and pasting. Wilson said the discussion would only be qualitative due to lack of data.
In some production and diagnostic labs it is almost a requirement that two people work in a biosafety cabinet, he added.
Ksiazek also brought up another issue related to arboviruses: Hunt said an online workshop participant commented that the ATCC characterizations are just for shipping purposes. Login or Register to save! Ksiazek discussed two comments in this section that were posted on the virtual town hall. Guidance written in language that engineers are familiar with would promote changes, considering that engineers often make changes based on regulatory requirements rather than being convinced to do so by risk assessments.
Ellis said an online workshop participant also prefers having both a digital and a hardcopy ; the participant also said that the hardcopy would be good for those who may not have access to the online version, such as labs in developing countries.
Ellis said perhaps it should be more clearly stated that all people must have some sort of eye protection. Ellis said a problem with this requirement arises if there are common open areas in the lab where people have their desks; are these people required to wear lab coats and eye protection when they are at their desks or only when working at the lab bench?
It would be beneficial if the BMBL would include language that empowers organizational leadership to present a detailed risk assessment as a justification to not employ a recommended practice that is written in the BMBL. Meechan said that hospitals are different from labs, the BMBL cannot advocate for humans to be put in level 4 containment because hospitals are not able to do this.
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.
Ellis also said there were several comments on updating LAI informationwhich are useful for risk assessments.
Biosafety in Microbiological and Biomedical Laboratories (BMBL) 5th Edition – CDC
Welch said there are labs, because of the type of research they perform, that do not necessarily require certified biosafety professionals. He said he thought this approach is adequate. 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. 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.
How is the team assembled?
Hunt said an online workshop participant commented that well characterized cell lines are not always tested for adventitious agents that can be introduced in GMP environments and that contamination cannot always be controlled.
Lawrence said there are federal activities under the offices of the White House, the Office of Science and Technology, and the National Security Council. Harbourt said the current BMBL allows lab workers to accomplish their goals using different methodologies and making it prescriptive would take away their flexibility. Wilson said the comments about DURC, gain of function, and other attendant technologies will be discussed with the OSP 37 so these topics could be addressed in a way that the information does not become out of date prior to the completion of the next BMBL edition.
Shea said she noticed some conflicting guidance in the BMBL concerning the use of PPE in lieu of primary containment in situations where primary containment is not feasible; there are sections that say this but other sections essentially say that all work will be done in primary containment—could a clarification be made as to which of these practices is considered best practice and could the contradiction be eliminated?
Welch said signs have impact on people who are editkon to the environment or who are foreign to it, such as maintenance workers or new employees, etc. He said he agrees with this approach. Bohn said unfunded mandates would make it difficult for people to find workable solutions; having only one way to do something is scary.
He also mentioned the following comments from the virtual town hall:. 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.
There should be a section on the importance of developing a strong safety culture. Moving information on the transmissibility of select agents in cage mates to the respective agent summary statements in Appendix D.