Leadership Issues in the Biosafety Profession
Dr Byron S. Tepper and I spent years running bench basic research at medical schools where we picked up lots of practical biosafety by personal experience in our laboratories and working with other bench researchers.
Hands on laboratory biomedical bench research experience, in my opinion, is required if individuals are going to help the biosafety field remain relevant.
I personally directed the second-year medical student/graduate student microbiology and immunology semester course with 80 hours of wet lab at a Philadelphia school of medicine in addition to working with the chief of infectious diseases (ID) on a book chapter, collaborating and publishing clinical research papers, and helping the ID department train new ID residents on diagnostic microbiology.
I mention this because the above clinical experience and my later collaboration with the former Johns Hopkins’ Chief of Infectious Diseases, Dr John Bartlett, at ID grand rounds as well as participating in the monthly hospital patient microbial disease reviews has led me to the conclusion that the clinical/medical side of biosafety [including CDC] is substantially different from biosafety as applied to biomedical bench research. Often, the bench and clinical research areas have different goals and outcomes.
An example of a recent, significant change in biosafety practice was removal of Biosafety Level Terminology from the World Health Organization’s Laboratory Biosafety Manual 4th Edition. The Forward to the 4th edition states: “Previous versions of the manual described the classification of biological agents and laboratories in terms of risk/hazard groups and biosafety/containment levels. While this may be a logical starting point for the handling and containment of biological agents, it has led to the misconception that the risk group of a biological agent directly corresponds to the biosafety level of a laboratory. In fact, the actual risk of a given scenario is influenced not only by the agent being handled, but also by the procedure being performed and the competency of the laboratory personnel engaging in the activity."
”In my opinion, this is a positive, significant change that will restore the scientific method to risk analysis. Biosafety Level terminology began in 1984 with BMBL 1st Edition. Health Canada removed biosafety levels a few years ago.” Dr Richard W Gilpin
BSL laboratory facility design specifications are currently available from the National Institutes of Health:
NIH Design Requirements Manual [Revised April 2019] and Desk Guide are the current BSL design reference - NOT the BMBL