So now, let’s look at reason number three – compliance with local, national and international regulations, standards and guidelines. It is very important to abide by the law, apply all standards and follow what the international community wants you to do. This is all about being a good neighbor for your community, your country and the world.

There are several international biorisk management standards that are addressed in a variety of international instruments, agreements and treaties. They obviously require coordination and partnership between different sectors – the public sector, the private sector and industry. On the left-hand side, I’m showing you some of the bigger things like treaties, conventions, resolutions and agreements. I’ll show you a few of those in a minute. Then you have more detailed regulations and directives that may be specific to your country. And finally, at local level, there are standards, guidelines, codes and manuals that we’ll talk about later on. Each of these are documents that have importance in trying to direct how you implement biorisk management, both nationally and locally.

One of the bigger international conventions that’s been around for a long time is the biological weapons convention from 1975, which is still in force today. There are a 165 state parties that have agreed to abide by it and twelve signatory states. It’s a nonproliferation convention, calling all the states and parties to adopt measures to prohibit or prevent biological weapons. This convention is reviewed and updated every five years.  

As part of the international agreements, there’s UN security council resolution 1540. It is legally binding on all UN member states. It says that all member states shall take and enforce effective measures to prevent the proliferation of nuclear, chemical or biological weapons. As you may know, many of the agents we deal with in our laboratories may be weaponized. Anthrax is a good example of something that has been used in a bad way. Therefore, there is reason to pay attention to these big, sweeping international resolutions and conventions. They do apply to you.

Getting a little more specific there’s the WHO public health mandate. As you know, the WHO was created by constitution in 1948. The world health assembly resolution, 55.16 from 2002 says there should be global public health response to natural occurrence, accidental release or deliberate use of biological and chemical agents and radio nuclear material that affects health. A very broad international sweeping resolution. In more detail, resolution 58.3 from 2005 says there should be prevention and control of the international spread of disease and public health risks. This is now more specifically speaking to the areas you work in public health and animal health. Finally, resolution 58.29 even more specifically says there should be enhancement of laboratory biosafety.

Here is the World Health Assembly resolution 58.29. It says to review safety of labs; follow the WHO guidance; implement safety programs; enhance compliance with biosafety guidelines; mobilize human and financial resources; cooperate with other ministries to facilitate access to personal protective equipment and encourage the development of biosafety training programs and competency standards. That last part speaks specifically to what we’re doing here today. The development of biosafety, training programs. I think after you’ve taken this course, you’ll be more comfortable with biorisk management and understand more about how those risks are controlled.

Another guidance standard that came out in 2005 was the international health regulations. These apply to any disease and public health events that could present significant harm to humans and animals. You can see in that graphic in the bottom that it came into force in June of 2007. There was a national action plan in 2009 and the core capabilities were presented with implementation by 2012. They’re still ongoing today, but there’s been difficulties with many countries in complying with all those practices and standards that were outlined. Again, this is one of those larger international standards and guidelines that help guide biorisk management.

The WHO guidelines on biosafety (first brought out in 1983) is probably the most widely used biosafety guideline in the world. The fourth edition was release in 2020. It’s used by many countries who lack their own national guidelines and standards. In addition, the WHO has also released some guidance on laboratory biosecurity and transportation of infectious substance. These are all important guidance documents that, on a big scale help you implement biorisk management at your institute.

Finally, the International Standards Organization has issued a laboratory biorisk management standard (ISO 35001:2019). This arose from the CEN working agreement on laboratory biorisk management called CWA 15793, first issued in 2008 and then 2011. Both of these are extremely good documents that really address laboratory biorisk management. I strongly encourage you to take a good look at these, even though it may be difficult to implement and come in compliance with all the different parts of it. It is an excellent framework document which will definitely help guide you as you develop your biorisk management program at your laboratories.

Turning to animal health, there is the World Animal Health Organization (or OIE) in Paris France. They have been developing standards for biologics and biosafety and biosecurity guidelines for veterinary laboratories and veterinary vaccine facilities for many years. They produce a manual of diagnostic tests and vaccines for terrestrial animals, which you can access online. Recently, they’ve released a revised guidance document on biosafety and biorisk assessment in animal health laboratories. I encourage you to go and take a look at that when you have a chance

Another international guidance document that you should be aware of is the global health security agenda that was launched in February of 2014. Their mission was to create a world safe and secure from infectious disease threats. It was created by a partnership of nearly fifty nations, international organizations and non-governmental stakeholders. The member countries identified eleven discrete action packages. Each of them had five-year targets with indicators to measure progress. It was action package number three that specifically spoke to biosafety and biosecurity. You can find out more about it at the link that I provided you there in green.

I would like you to stop here for a minute and think about what laws might be relevant to you at your work site. There may be labor laws biomedical waste disposal laws, occupational health laws and many others. It’s very important for you to know what you should be doing as far as your work is concerned, and what your employer’s responsibility are to you. Often people don’t fully understand what laws are in effect, because there’s no enforcement of these laws. There may not be any inspectors that come out to check on compliance and therefore people are not aware of the laws. Stop here, take as much time as you need to do some research on the internet. Take a look and see what laws apply to you in your country and in your facilities.

Let’s do a bit of a quick review. As I mentioned, there are many national and international regulations and guidelines that should be followed regarding the safe use of pathogens. There are a lot of international documents that your government should be aware or have agreed to abide by, all of which they hopefully have communicated to you. The world does care about how you handle biohazardous material and wants you to comply. Non-compliance can result in fines, job loss, imprisonment and embarrassment. Therefore, it’s very important to understand what the rules laws, regulations guidance documents are and do the very best you can to follow them.