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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Patricia Delarosa NIH said she thinks 44th 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.

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Could the definition include the criteria under which not following the guideline is expected or is acceptable? Bmbk other comment was about having a written security plan. Available online at http: Hunt said four online workshop participants commented that the BMBL should remain performance based ; she also shared the following comments from the online workshop participants:. Yeakle said that based on a risk assessment that her lab conducted, using Rubbermaid boxes to move nonhuman primates put their personnel at risk more than the animal.

Ellis commented that one aspect of this issue is the volume editjon the manufacturing side handles versus the volume being administered; this is about risk assessment and judgment call, he said.

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He said the agent summary statements are great in terms of how they are written and that they provide a lot of information, but they are not always consistent with each other, whereas the MSDS have a very consistent format. Page 11 Share Cite. It would be great to have some reference to what eye protection should be worn in a clinical diagnostic lab versus bench work versus biosafety work.

Wilson said there is an executive BMBL steering committee, 2 composed of federal employees, and an editorial board that is also composed of federal bmlb from different agencies and mission partners.


He mentioned hearing about a lot of confusion during the Ebola outbreak and now there is confusion with the Zika virus because of the Zika-Chik 39 Dengue relationship and the listing of Chik as a BSL-3 agent; does this mean that any suspect Zika sample in a editioj lab has to be diagnosed in BSL-3?

Wilson said the federal policy on DURC is very narrow right now, so they will take a narrow view. Ksiazek said the generally accepted procedure is not taking the waste to the dump; the formal procedure is to decontaminate it in an autoclave or to hand it over to commercial waste disposal companies.

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

Yeakle reminded participants that engineering controls in the lab are intended to prevent an agent from contaminating the lab while moving animals; to avoid creating a hazard for the lab employees the lab needs to be decontaminated if the animal is not in some kind of a primary containment device.

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 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.

How is the team assembled? Wilson said this is an issue that has been discussed before and still has not been resolved.

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

Shea clarified that determining the root cause would be more for writing modern and accurate risk assessments. Are the current agent summary statements adequate or should the content be changed? Meechan mentioned saying something general about these technologies in the BMBL and not going into details that are too fluid. He said he agrees with this approach. Salerno also said that diagnostic and medical labs have relatively sophisticated quality management systems, which they are required to have, that embrace this approach.

Hunt said the need for biosafety professionals should be emphasized to elevate the status of this professional category. Page 19 Share Cite. She asked if the format should be retained or if the MSDS format should be used.


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. 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: Ellis also said there were several comments on updating LAI informationwhich are useful for risk assessments.

He said researchers are needed who will be funded to do this, and the only way this can be done is by 4tth applied biosafety research programs. Morland said the ATCC characterization of a material does not equate to how it should be handled and this is why Appendix H is useful to have.

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.

He suggested providing an overview and then making references to these websites. He said there should be a way to hire people to do experiments that address issues that lab workers have to deal with.

Ellis asked if there might be a way to address this issue from a risk assessment standpoint. 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. Hunt also mentioned the following comments that were posted on the virtual town hall:. 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.