According to the World Health Organisation (WHO): “Biosafety is a strategic and integrated approach to analysing and managing relevant risks to human, animal and plant life and health and associated risks for the environment.” It recognises that there are links between sectors and the potential for hazards to move within and between sectors, with serious consequences. It addresses the containment guidelines, technologies and practices that are put in place to prevent the accidental exposure to toxins and pathogens. Responsible practices (biosafety) are the only effective way to ensure that living organisms and the environment stay safe.
The concept of biosafety has been around since the late 1800s when safety measures were introduced after there were reports of diseases being found in laboratory personnel.
Biosafety Concepts and Standards
Biological Hazards: The potential risk of uncontrolled exposure to biological agents that can cause disease.
Biocontainment: Procedures used to prevent infectious diseases from leaking from research centres and laboratories.
Bioprotection: A set of measures that are taken to reduce the risk of theft, loss, misuse or intentional release of infectious agents including those who are in charge of access to facilities, materials storage and data and publication policies.
Standards: Researchers who work closely with potentially contaminated biological agents have to be aware of the risks and learn the techniques and practices required to do their jobs safely.
Universality: All biosafety procedures must be observed and followed by everyone as anyone has a risk of carrying and spreading pathogenic microorganisms.
Barriers: The elements that are used to contain biological contamination are divided into two categories: immunisation (vaccines) and primary barriers: safety equipment like gloves, protective suits and masks, and secondary barriers including insulated work areas, hand washing areas and adequate ventilation systems.
Elimination: All the waste generated must be disposed of in strict accordance with the specific procedures set out for each hazardous material.
Biosafety Levels
Pathogens are defined as infectious agents that can cause disease in humans and other living organisms. Here are the different levels of pathogen risk groups that can be found in CRO laboratories:
Risk Group 1
Has the lowest risk to living organisms and the environment and is unlikely to cause any disease.
Risk Group 2
Pathogens that pose a moderate risk to living organisms and a lower risk to the environment. Includes microorganisms that can cause disease but has treatments that are available, and the risk of spread is low.
Risk Group 3
Pathogens that are of a higher risk to living organisms and a moderate risk to the environment. Includes microorganisms that cause diseases that can be potentially serious. Treatment is available but can be more expensive and harder to come by. There is also a higher risk of the disease spreading.
Risk Group 4
Pathogens that have a high risk to living organisms and the environment. These microorganisms can cause life-threatening diseases that can easily spread. Treatments are not usually available.
Physical Containment
Physical containment facilities are places that are able to handle and manage microorganisms safely. These facilities are important because they reduce and prevent the risk of pathogens being released into the public.
Physical Containment Level 1 Facility
This type of facility is suitable for low-hazard microorganisms such as Risk Level 1 organism. Researchers are easily protected by the procedures that are in place, and Personal Protective Equipment (PPE) includes closed shoes and a lab coat.
Physical Containment Level 2 Facility
Suitable for hosting Risk Level 2 organisms including research and diagnostic practices. PPE includes closed shoes, a lab coat and protective eye gear. All PPE needs to be decontaminated before being removed.
Physical Containment Level 3 Facility
Used for research and diagnostic practices for Risk Level 3 organisms. These facilities usually have additional building features that help by minimising the risk of infection. PPE that is required in these facilities includes lab coats, closed shoes, protective eye gear and gloves. The PPE is usually discarded after use.
Physical Containment Level 4 Facility
Suitable for research and diagnostic practices for Risk Level 4 organisms. This facility is separated from other buildings and has a shower in/out and ventilation and decontamination systems.
Regulations
International Health Regulations
The International Health Regulations (IHR) is an international law and is legally binding in 196 countries. The purpose of the IHR is to “prevent, protect against, control and provide a public health response to the international spread of disease.” It refers to diseases that may cause significant harm to humans - no matter their origin. Health security strategies need to be aware of a diverse range of threats including natural outbreaks, pandemics, bioterrorism attacks and biological warfare.
Building laboratory functions and capabilities to support a public health system can’t be done effectively without a strong focus on biosafety.
Biological Weapons Convention
The Biological Weapons Convention (BWC) is the first international treaty that banned the production and use of an entire category of weapons. It was entered into force in 1975 and includes exchanges of information between laboratories, research centres, vaccine production facilities and cases of unusual outbreaks of infectious diseases. It relies on international cooperation in regards to biosafety and biosecurity at both regional and international levels which will in turn prevent the development, acquisition or use of biological and toxin weapons.
Administrative and legislative measures to enhance compliance with the BWC include awareness and outreach, education, biosafety and biosecurity and disease surveillance, detection and containment.
Cartagena Protocol
The Cartagena Protocol on Biosafety to the Convention on Biological Diversity (2000) outlines in Article 18 that Living Modified Organisms that are moved around should be handled, packaged and transported safely and in accordance with the relevant international rules and standards.