Welcome to this introduction to biosafety, biorisk management and why it is important. In this lesson, I want to introduce you to biosafety, biosecurity and the reasons why you should learn biorisk management. Simply put, the world can be a dangerous place and you can get hurt in many ways. One of which is to get sick or die from an infectious disease. In this series of lessons on biosafety we will discuss the basics of keeping yourself safe from infectious diseases, controlling the spread of pathogens and how to manage biorisk in a variety of situations and circumstances. There is something to learn for everyone, no matter who you are or what you do. The threat is real – so let’s get started.

So, what is biosafety? If you a member of the public, biosafety is just a part of public health. Here you see one definition of biosafety from Wikipedia. The most important part of this definition is that biosafety is “the science and art of preventing disease”. Biosafety is part science and part making the right choice (the art part). For those working in a biomedical facility, the definition is more laboratory focused as shown here, which talks about using three different types of controls to manage risk. We’re going to explore all the parts of this later on, as we go deeper and deeper into this whole series of modules on biological safety and biorisk management.

So what is the threat? For these lessons we are going to refer to the threat as a biohazard? This is a potential hazard to humans, animals or the environment caused by a biological organism or by material produced by such an organism (for example a toxin). Biohazards are everywhere. Fortunately, most of them are not that dangerous, however many may be. These can make you sick or even cause death. For most of the general public, the greatest reservoir of pathogens and risk of infection comes from other humans. For those of you who work in a biomedical facility, the biohazard are the organisms that you routinely work with or handle, such as viruses, bacteria, fungi, parasites and all the different products that may come from those. In addition, any body fluids or tissues from humans or animals, transformed cell lines and certain types of nucleic acid may also all be considered biohazardous.

Based upon recent estimates, there are over 1400 known infectious diseases to humans, of which approximately 800 can be transmitted from animals to man. In addition to the known existing infectious diseases, there are also lots of other diseases that are consider to be emerging or reemerging. Biology is always creating new types of life, trying to find new areas where it can continue its existence. Therefore, the presence of unknown or uncategorized pathogens is always a continuing threat. These pathogens may be found in samples from people, animals or the environment in any submissions to a laboratory. It seems that every few years a new threating pathogen makes the news and begins to spread.

Here are just a few examples of what I am referring to. Let’s start with Mad cow disease. This was a prion disease that spilled over from sheep to cattle. Prions are not living organisms, but are simply misfolded proteins that reshape normal proteins, thereby causing disease. These, misfolded proteins transmitted from sheep to cattle when there was a change in the feed cattle were given. This disease, you may know also affected humans. Several hundred people became sick from eating cattle that had the disease. This was called variant Creutzfeldt Jakob disease. An interesting, emerging infectious disease that we created through our practices of how we were handling animal feed. But then, once that practice went away, the disease also went away.

Bird flu – another great example of a continuing emerging infectious disease. For a long time, influenza was thought to be confined to species. Only certain types were found in man and certain types in birds and other mammals. But then a bird strain (H5N1) transmitted from birds to people. So, now birds became an important reservoir of influenza threat to humans as well.

Middle East respiratory syndrome or MERSCov, as it was called, also emerged several years ago. You can see there that as late as 2013, it was in Saudi Arabia, some in Egypt and a couple of other middle eastern countries. It was a disease that was thought to have a reservoir in camels and then transmitted to people. Where did it come from, why all of a sudden did it cause disease in people, where did it go and will it appear again?

Ebola, another disease that’s been around for quite a long time. The reservoir is thought to be in monkeys in Africa and it occasionally infects humans causing outbreaks. There’s been some very serious occurrences in the Democratic Republic of Congo in the last several years. These outbreaks are very difficult to get under control and a large number of people are infected and die. The disease has a very high case fatality rate and is therefore a great concern to health care workers and those working in biomedical facilities. It is estimated that approximately fifty percent of people that get infected go on to die. So, there’s great concern over this disease. Again, an emerging and reemerging infectious disease that comes and goes over the years which I’m sure we’ll see more of. 

Most recently the world experienced COVID-19 – where did that come from? People think there is a reservoir in bats in Asia. It was transmitted into people and then spread around the world. This global pandemic is turning out to be the worst in modern history and has challenged health care facilities to respond. More coronavirus variants could also be on the way.

So you see the threat is real. There are a lot of known and emerging pathogens in the world. In addition to these pathogens having a safety risk, they are also a security risk. Since some of these agents are very dangerous to animals and people, they can also be used by somebody in an inappropriate manner. There are a number of pathogens that can be distributed or used to create bioterror in a variety of countries. Things like botulinum or ricin toxin or anthrax that was mailed through the mail system in the United States in 2011. If you work with these high-risk agents, you need to be concerned with who has access to these pathogens, how they are being used and what information about them is released about them? The biomedical community has the responsibility to safeguard these pathogens. Therefore, there is a strong overlap between biosafety and biosecurity.

This picture, from the World Health Organization shows the integration of biosafety and biosecurity coming together in one package called biorisk. The concept of biosafety (working safely) and biosecurity (keeping that work safe) all coming together to create global public health security is very important. So, when you think about biorisk management and handling biological agents, it is really about global public health security and the two aspects of working safely and securely with the pathogens that you have been entrusted with.

Therefore, the definition of biorisk management, as adapted from OHSAS 18001:2007 as shown here mentions both safety and security as it defines the management program. This management system is a set of interrelated elements used to establish policy and objectives. To achieve those objectives, the management system includes organizational structure, planning activities (for example, risk assessment and setting of objectives), responsibilities, practices, procedures, processes and resources.

In addition to recognizing that biorisk has a safety and security component, you also need to recognize that there are overlaps between human health, animal health the environment and National security. As you know there are human pathogens, animal pathogens and zoonotic pathogens many of which have reservoirs in the environment. Since some of these pathogens have a potential to be misused, we have this overlay of National security. So, you can see there are a lot of risks and they are shared risks, with shared interests. Since they are overlapping, you may find yourself right in the middle of those four parts when working in your biomedical community to address the human health, animal health, environmental and national security concerns.

Now that you understand biosafety, biosecurity and biorisk management let’s turn to the why. What is the importance of biorisk management? Why would you want to pay attention to this subject? What’s important about it. In this lesson, I’m going give you five basic and very simple reasons. But before I give you those five, let’s just step back and look at the big picture. As you already know, microbial pathogens are everywhere. Their goal is to survive. One way to do that, is to enter our bodies and reproduce. Biological safety is about recognizing where and when that risk can occur and how to stop it. If you don’t, mistakes can occur and people can get ill, die or environmental contamination can occur. Speaking of mistakes. Let’s just take a look at a few examples of biorisk management errors. Events that you don’t want to have happening to you or in your facilities.

For example, in the kitchen you should never use the same knife to first cut up a raw chicken and then cut up lettuce. Microbial agents are present on chicken, which will then be transferred to the lettuce that will be eaten raw. If you clean the knife between the chicken and the lettuce or use different knives, that will prevent this mistake.

In this recent incident shown here, several people became sick and one person died with an E. coli infection after having contact with animals at a petting zoo. Good hand hygiene practices may have prevented this.

Here is another example of poor training, leading to poor handling of Salmonella in teaching laboratories. In this event the Centers for Disease Control in the USA, tracked 73 infections in 35 states, in various microbiology teaching laboratories. Students were handling Salmonella typhimurium with poor biorisk management practices, leading to one death and many illnesses.   

These types of incidents are worldwide. This report shows the incidence of laboratory acquired infections of Brucella in a diagnostic laboratory in Turkey. This study showed that 6% of laboratory workers were infected with Brucella, doing routine diagnostic work. Clearly an unacceptable high rate of infections, pointing to a failure in biorisk management.

I am just going to show you one more incident, but there are many, many more. This biorisk management error did not cause any deaths, but led to huge financial loss. In this biorisk management incident, foot and mouth disease, escaped from a vaccine manufacturing plant and caused an outbreak in cattle and sheep in England. Because England was free of foot and mouth disease it caused a huge financial loss for the agriculture industry and cost the government a lot of money to restore the country to FMD freedom.

To summarize this first part, I want to remind you that the threat is real. There are a lot of pathogens in the world and if you work in a biomedical facility in any capacity, you have the responsibility to handle these safely and securely. Now in part two of this module, I am going to give you the five most important reasons you must study and understand biorisk management.