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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The MSDS format is preferred. Final Thoughts After the discussion of the BMBL sections and appendices, Editoin asked the workshop participants to address the following issues that she mentioned at the beginning of the workshop: The discussion of risk assessment was a little dismissive.

He said in terms of immunizations it should be made clear that IND vaccines are no longer available and risks should be addressed in other ways.

There are allowances for handling an unknown sample in a clinical lab until you know what the sample is, he added. Bohn said it would be nice to have an online version that can be easily printed out and easily updated if necessary, one that is compartmentalized.

Bmmbl said there are occasional clinical reports that could be incorporated. Ellis commented that as changes arise, how can the BMBL be updated without having to rewrite and republish the full document?

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.

Harbourt said what can be done depends on institutional policy or the procedure itself; there are times when biosafety professionals have limited flexibility as to what containment equipment or devices they can work with. 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.

She asked the workshop participants if information in the BMBL should be consolidated and not presented repeatedly. 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.

Hunt said an online workshop participant commented that it should definitely be performance based; with the multiplicity of public health and biosafety challenges and research avenues, and the accelerating rate of technological change in response to these challenges, any prescriptive approaches in the BMBL 6th Edition would most likely be obsolete upon publication; even real-time, web-based curation of the new edition would require constant updating of prescriptive procedures.


Hunt said another online workshop participant commented that the online version would be essential for addressing the inevitable and needed amendments. Lawrence said there are federal activities under the offices of the White House, the Office of Science and Technology, and the National Security Council.

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. He said maybe a practical statement can be made about this. 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 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. Wilson explained that the errors could be due to the redundancy in presenting information, which entailed erition lot of copying and pasting. He added that they cannot go into the details of the current policies because they might be different by the time the next BMBL edition is published.

Emphasizing that droplets, not just aerosols, contaminate the environment and might also be part of the covert exposure that might be experienced. Ksiazek said he thinks we are getting dangerously close to losing our ability to ship some stuff and we need to do something about it—what can be done? Hunt said developing a strong safety culture could also be an institutional issue.

He also commented that he finds the agent summary statements to be more useful edution the Canadian Public Health Lab summary sheets for doing risk assessments. Ellis said he agrees that it should remain performance based. Hunt said there was a comment posted on the virtual town hall about text under Recommended Practices page Adding a little bit more risk assessment information on toxins.

Biosafety in Microbiological and Biomedical Laboratories (BMBL) 5th Edition – CDC

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 bnbl 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 edittion and could the contradiction be eliminated?

Page 19 Share Cite. Ellis said the comment included a suggestion to add a small guide to tools for risk reduction, hierarchy of editkon, risk assessment methods, and risk reduction methods and metrics to the BMBL.


Keep in mind that the BMBL is used as a basis for guidelines in other countries. Bohn said it would be worthwhile to have this discussion especially if it shows that administrative controls, safety practices, use of PPE, and engineering controls help reduce LAIs. Hart said that while 4ht BMBL was originally written more for academia and research, it is used by diagnostic labs and public health labs. She suggested dovetailing those recommended positions with the BMBL guidelines on good governance.

Page 12 Share Cite.

Ellis said this is an excellent comment that was not posted on virtual town hall and that it would be good to address it. Proceedings of a Workshop. Wilson said she thinks the comment is not about reviewing this section in the BMBL annually but that occupational health programs or medical response programs need to be reviewed annually based on the portfolio. 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.

Biosafety in Microbiological and Biomedical Laboratories (BMBL) 5th Edition

Yeakle said she thinks there is value in having both an online version and a hardcopy. Wilson said the federal policy on DURC is very narrow right now, so they will take a narrow view.

Reynolds Ren Salerno CDC said the inability to know what is going on editiin to make evidence-based biosafety decisions is due to the current culture, which does not encourage reporting; the practice of trying to find a single root cause of an accident and penalizing the individual who made the mistake prevents the reporting of LAIs, accidents, and near-misses.

Ellis said signage in a BSL-1 lab is helpful because it would alert people who might be at risk immunocompromised etc. Major themes from the virtual town hall meeting were further discussed in a workshop held on bmbbl May in Washington, DC. Ellis said he thinks the document only covers day-to-day lab orientation and management and other topics that are not covered in the BMBL from a clinical and diagnostic lab standpoint.

Harbourt asked if the BMBL editors would consider addressing the minimum performance criteria for downdraft tables because their use is currently in vogue, particularly for certain procedures in ABSL 29 -3 and ABSL-4 labs.