Safety/Learn More/TBRA Transcript
Transcript of video "Traditional Biological Risk Assessment"
Hello. My name is Terry Johnson, I'm a Bioengineering lecturer here at UC Berkeley, and today we're going to talk about Traditional Biological Risk Assessment.
We typically look to the NIH Guidelines for Research Involving Recombinant DNA Molecules, to guide us in our research. By "we", I mean your lab, but I also mean your organization's office for guidance and oversight. Here at Berkeley, that's EH&S: Environmental Health and Safety. While both of these organizations (your lab and your office for guidance and oversight) should be aware of the NIH Guidelines, much of the conversation happens between the two of you. An example of this would be a Biological Use Authorization. And this is paperwork that we fill out here at Berkeley, and give to EH&S to make them aware of the types of experiments that are going on in the lab, so that they can best advise us to work safely and responsibly.
Let's take a moment to discuss how safe and responsible work is enforced. In extreme cases there are punishments, and these can include loss of permits, fines, shutting down the lab, or even jail time (for misuse of select agents, which are typically associated with bioterrorism or biowarfare). More commonly, there are administrative controls. This would be something like: if you attempted to order a dangerous bacterium, the supplier would ask for paperwork that demonstrated that you were capable of working safely with that bacterium. If you couldn't provide the paperwork, the supplier will reject the request. It's important to note that the administrative controls are no substitute for a researcher's active consideration of biosafety and biosecurity. These are here to help you, but they're no replacement for common sense and your expertise.
It is important for a researcher to be aware of any biohazardous agents that are used in their work. These are infectious or pathogenic agents capable of causing disease in healthy humans, plants, and animals. Typically these would include bacteria, viruses, fungi, or parasites. To assess the risk of a particular agent, one must consider the following factors: the virulence, pathogenicity, or infectious dose of the agent; the environmental stability of the agent; its route of spread or communicability; the quantity, concentration, or volume to be used in the experiments; the availability of a vaccine or treatment for the agent; and the allergenicity of the agent.
After considering all of the factors, a particular agent will be given a Risk Group classification. Risk Group 1 agents are not associated with disease in healthy adult humans. An example of this would be non-pathogenic E. coli. Risk Group 2 agents are associated with human disease which is rarely serious, readily preventable, or treatable. An example of this would be Salmonella. Risk Group 3 agents are associated with serious human disease, for which interventions may be available. For example, HIV. Lastly, Risk Group 4 agents are likely to cause serious or lethal human disease, for which interventions are not usually available. An example of this would be Ebola.
For each Risk Group there's a set of Biosafety Level procedures associated with working safely with those agents. Biosafety Level 1, for working with Risk Group 1 agents, involves wearing gloves and masks, and standard decontamination of waste. Biosafety Level 2 procedures add risk-specific training, limiting access to the lab, sharps precautions, and the physical containment of experiments (when appropriate). Biosafety Level 3 procedures include pathogens / lethal agent training, routine physical containment of experiments, and restricted access to a specialized lab. Biosafety Level 4 procedures include restricted access to a much more highly specialized lab, and extensive further training. There are relatively few labs that are rated to work at Biosafety Level 4.
To work safely with a novel organism, one should assign it a Risk Group. In this, we're aided by Appendix B of the NIH Recombinant DNA Guidelines. Here, researchers can compare a potential agent of their design to existing agents which have already been assigned a Risk Group. It's critical to note, however, that for novel experiments, the researcher must make risk assessment part of the design process. You don't want to build anything before you know how to work safely with it.
Earlier, we mentioned Select Agents, which are regulated by the group shown here. These are typically potential bioterrorism or biowarfare agents. They may affect humans, animals, and/or plants. They include whole organisms and individual toxins. They require extensive permits to work with, and violations of the rules for select agents have severe penalties.
Here is a partial list of select agents. Some of these may be familiar to you -- for example, the bacteria which causes anthrax. While this is naturally occurring, things that have been engineered can appear as well. For example, the reconstructed 1918 flu. Let's take a closer look at botulinum neurotoxin. Now, why would we particularly be interested in this?
Because of its potential for what we call "Dual Use". When considering questions of dual use, you must ask yourself: can your work, or part of your work, cause harm in the hands of: the unscrupulous? or the incautious? For example, let's say you were interested in producing botulinum toxin, or Botox, in bacteria. It has a number of medical uses, and that's the purpose of your work. However, the information generated by your work, and the physical product generated by your work, could potentially cause harm in the hands of others.
In summary, you should be aware of: the organization or organizations overseeing your work, the appropriate Risk Group for the organisms that you're working with, and any select agents that might be involved. Further consider: any potentials for dual use, and especially if there are any biosafety or biosecurity concerns that are not addressed by current administrative controls.