Hello, everybody and welcome back. In this module I will be giving you an overview of biorisk management. This is the entire course in a snapshot and therefore good if you want to give people an brief introduction to biosafety. This module will introduce you to some of the concepts of risk management in the laboratory and what you can do to lower the risks.

Biorisk management follows the typical risk management process where you start with identifying the hazards? Then determine the risk from that hazard? Next use controls to mitigate or lower the risks. And finally, manage and evaluate the risk mitigation process to ensure you are doing a good job and the mitigation is working. This loops around in a circle to go back to an assessment again if we realize that there are some problems or you need to adjust. In addition, we also do this on a regular basis, because we know that things change. Therefore, biorisk management is a never-ending cycle of improvement repeated on a regular basis.

Let me begin with a few definitions and terms, so they were all on the same page. Laboratory biosafety, is a set of preventative measures designed to reduce the risk of accidental exposure or release of a biological hazard. Laboratory biosecurity is a set of preventative measures designed to reduce the risk of intentional removal or miss use of a valuable biological material. Biosafety and biosecurity have a common strategy and they are both implemented on a graded level of protection, based on the risk. Biosafety and biosecurity must always be applied in an integrated system that avoids compromising the necessary infectious disease research or diagnostic work being done. The work must still take precedence, but you must do that work safely and securely.

Biorisk management uses a layered system of defenses to lower the risk to an acceptable level. This layered system of defense employs several different controls at the same time. You might think about it like putting together multiple layers of cloth – one on top of each other to make it stronger. Anytime you put together multiple layers of anything you make things stronger. Therefore, while any one control may be good, more of them in a layered fashion is better. In addition, you need to put your defenses together in a strategy that works for you and makes sense for the situation. Think about adding your controls in a graded fashion where one control adds to another and complements each other.

First, let me remind you that infections of people and animals from pathogens get into the body through a variety of different means. The primary ones are first the mucous membranes of the face (eyes, nose and mouth). Second, the respiratory tract because we are always breathing and the work that we do in the laboratory or vivarium may create aerosols of microorganisms. Third ingestion via the mouth or nose. Fourth, through the skin if it is broken or abraded (you are cut or scratched in some way). Many of the biosafety controls work by blocking the microorganism’s route of entry into the body via these routes.

Another important aspect that you need to remember and think about is the chain of infection. The chain begins with the pathogen and ends with disease in a person or animal. First, the pathogen exists somewhere in a reservoir, as you see on the upper part of this slide. This maybe in a Petri dishes, Ependorph or Falcon tube or maybe in an animal. It may also reside on the surface of your gloves, phone, or bench. Or if you are in the field, it could be in the soil, air, or water. The pathogen then finds its way into a susceptible host (human or animal) via a portal of escape from the reservoir and one or more routes of transmission. Routes of transmission include the air, splatter, ingestion, percutaneous injury, or arthropod vector. If, the host is resistant then the pathogen may not cause an infection. If the host is susceptible there is typically some incubation period before signs of infection are seen. The incubation period could be as short as 24 hours or as long as 10-15 days, depending on the pathogen. After the incubation period there may or may not be some signs of illness, such as fever, vomiting, diarrhea, or lethargy.

This is the chain of infection. The risk assessment should look at the entire chain of infection from the top to the bottom. From that understanding, you then apply controls to break that chain of infection. You are trying to break the chain at all points, from stopping the escape from the reservoir to preventing illness. In addition to breaking the chain, you can also use immunization as means to change the host’s susceptibility. Finally, we add surveillance to look for illness or some signs that there may have been an infection and therefore the chain was not broken. This is a very important slide that explains a lot about disease transmission, infection and how biosafety can be used to prevent illness.

Now I want to introduce you to the hierarchy of controls. This is the same for biosafety, as it is in any other safety industry. Most industries talk about five controls, elimination, modification (including substitution and simplification), engineering controls, administrative controls, and personal protective equipment (PPE). Later you will learn how you can employ these controls, in a layered fashion, with the resources you have, to try to help break the chain of infection.

Another way to look at these controls is to group them into three different baskets. This may be a little easier for people to understand because this is more practical and the way we see the world in our laboratories. First, practices and techniques – the things that we do as we handle the pathogens in the laboratory or animal room. Second, the safety equipment used, which is often considered primary containment or barriers. This includes the biosafety cabinet and the PPE that is worn while working with the pathogens. Finally, the third element is the room that you are working in – the facility design, which is called the secondary or tertiary containment. The mix of these three controls is what is important and what should be dictated by the risk assessment. As shown here, the three parts are mixing equally, coming together in the middle to form the best combination of controls. But the exact mix of the three should be dictated by the specific situation you find yourself, where you are doing the work, what the hazards are, what the risks are and what resources you have. For example, you may be working the field and have no biosafety cabinet and no room to work in. You may only have your skill and limited PPE.