Biosafety is the containment principles, technologies and practices that are implemented to prevent the unintentional exposure to biological agents, toxins, and material or their accidental release.
Why is biosafety required?
The main reason for ensuring that biosafety requirements are in place in a research or teaching facility is to minimize the exposure to potentially hazardous biological agents, toxins and material. Some biological agents like certain bacteria, viruses, fungi, protozoans and prions handled for research purposes have the ability to cause infections in the personnel who handle them if they get exposed to them unintentionally. These infections are commonly referred to as ‘Laboratory Acquired Infections’ or LAIs to differentiate them from infections people can get through the community. Similarly certain other biological material like animal dander, fur and fungal spores have the capability of causing allergies in susceptible personnel. These are referred to as ‘Laboratory Acquired Allergies’ or LAAs. Certain toxins of biological origin can have serious adverse effects on the personnel who handle them if exposed to them unintentionally.
On the other hand the accidental release of hazardous biological agents or material to the outside environment can be a significant concern to the public, to animals or plants in the environment or to the general environment based on the hazardous properties of the biological agent or material.
Due to these reasons, it is essential that biosafety requirements are implemented in any facility that handle potentially hazardous biological agents, toxins or any other biological material such as material of human origin, live animals, material of animal origin, whole plants, material of plant origin, and environmental, food or other types of biological samples that has the potential to contain hazardous biological agents or toxins.
AS/NZS 2243.3: 2010 Laboratory safety, microbiological safety and containment, is the main resource that gives information on biosafety principles and practices in Australia.
To access AS/NZS 2243.3:
Go to Library -> Under Databases go to ‘S’ -> Select ‘Standards Online Premium’ -> Agree to the terms and conditions -> Sign in using La Trobe staff / student account details -> search for 2243.3.
Principles of biosafety
The core components of biosafety are risk assessment and containment.
Risk assessment is the systematic process of identifying hazards, evaluating risks and determining controls.
A hazard can be defined as a source that has the potential to cause harm or an adverse event while risk is the actual harm or adverse event that can occur due to the hazard. In evaluating risk usually two factors are considered:
- Likelihood – The possibility for a harm or adverse event to occur
- Severity – The seriousness of the harm or adverse event
The product of likelihood and severity determines the actual risk.
Controls are the microbiological practices, safety equipment, and the facility safeguards required to prevent or minimize the evaluated risks.
The Research Office has recently introduced a risk management form to formally document the risk assessment process for hazardous biological work. All researchers who are handling hazardous biological agents, toxins and / or material during the course of their work are advised to contact the senior biosafety advisor to find out more details about this process.
When should a risk assessment be carried out?
A risk assessment needs to be conducted before starting work with hazardous biological agents, toxins and / or material.
Who should be involved in the risk assessment?
Generally speaking it is important that the main person conducting the risk assessment be the person who is going to do the actual work as he or she will be the person who is most familiar with all aspects of the proposed work. For students and staff who are going to undertake a new project or procedure for the first time, it is important that the principle investigator or senior laboratory members are consulted during the risk assessment process to ensure that all hazards and risks have been identified and the proposed controls are effective. In addition inputs from laboratory services managers / technical officers too can be sought when common equipment / facilities are proposed to be used. If a new equipment is going to be used it would be necessary to consult technical support personnel to get a complete understanding about the equipment including potential hazards and risks while inputs from an area specialist would be required if a new procedure or technique is proposed to be attempted. The senior biosafety advisor can be consulted for broader issues pertaining to biosafety.
What need to be considered in carrying out a risk assessment?
When conducting a risk assessment for work with hazardous biological agents or material three aspects need to be generally considered. These are:
Coming up with risk controls
Once the risks associated with a work procedure or a project have been identified the next step would be to come up with appropriate controls to minimize or prevent the risks. The following hierarchy of controls must be considered in coming up with controls where elimination is the most effective and personal protective equipment (PPE) is the least effective:
* Engineering controls
* Administrative controls
* Personal protective equipment (PPE)
Although trying to eliminate an identified risk (e.g. getting rid of the need for an open flame by using disposable sterile loops) or attempting to substitute a hazardous material / agent / process with a less hazardous one (e.g. using an attenuated strain in place of a wild type strain) are the most effective types of controls, there are many instances when proposed work may not necessarily allow elimination or substitution. Therefore engineering controls and administrative controls are the most commonly adopted controls to minimize or prevent identified risks.
Examples of some commonly used engineering controls include biological safety cabinets and aerosol containment devices for centrifuges, when working with hazardous biological agents and / or material. It is important that these engineering controls be maintained / serviced / certified on a regular basis to ensure their correct functionality. In addition it is also imperative that laboratory personnel are well aware of how to correctly use these equipment. Malfunctioning engineering controls or improper use of these controls can increase the risks rather than decrease them as the laboratory personnel would then be working under a false sense of security.
Some examples for administrative controls include following standard operating procedures, putting up signage, going through training, ensuring correct labelling and carrying out periodic inspections.
Although considered the least effective control, personal protective equipment (PPE) such as gloves, lab gowns, covered shoes, eye and respiratory protective equipment, still provide a considerable degree of protection to personnel against hazardous material / agents handled. But to get the correct degree of safety, it is important that the correct type of PPE is selected based on the procedure to be used, and that they are used correctly. If applicable PPE also need to inspected and maintained on a regular basis (e.g. respirators).
When should the risk assessment be reviewed?
All risk assessments need to be reviewed at pre-determined regular intervals. The initial risk assessment must be reviewed whenever there are changes to the agents /material, practices, personnel, equipment, location or any other aspect of work that may have an impact on risk. Risk assessments also need to be reviewed following an accident, incident or a near miss.
Containment is the collective term used to describe the combination of buildings, engineering function, equipment, and worker practices used for handling hazardous biological agents and material. As was described under risk assessment, the risks associated with different biological agents and material vary. To address these varying levels of risk, differing levels of containment are required. These levels known as physical containment are described under four levels from physical containment level 1 (PC1) to physical containment level 4 (PC4) where PC1 can be used to work with biological agents and material of the lowest risk up to PC4 which need to be used for working with biological agents and material of the highest risk. Although there could be some exceptions, it is usually accepted that a biological agent or material that belong to risk group 1 should be handled under physical containment level 1 (PC1) while biological agents or material that belong to risk groups 2, 3 and 4 need to be handled at under physical containment (PC) levels 2,3 and 4 respectively.
AS / NZS 2243.3: 2010 gives the construction requirements and work practices that need to be followed at each physical containment level for 4 types of facilities as given below:
- Laboratory containment facilities for working with microorganisms (from PC1 – PC4)
- Animal containment facilities (from PC1 – PC4)
- Plant containment facilities (from PC1 – PC4)
- Invertebrate containment facilities (from PC1 – PC4)
At present the La Trobe University has only PC1 and PC2 facilities.
Working in a PC2 laboratory
PC2 laboratories need to be used when working with,
- Risk group 2 microorganisms / biological agents
- Any biological toxin that can safely be handled in a PC2 laboratory
- Any biological material that could actually or potentially include a risk group 2 microorganism / biological agent or any biological toxin that can safely be handled in a PC2 laboratory.
The following links give some general information on working safely in a PC2 laboratory.
Note: Above information is based mainly on the safe work practices given in AS / NZS 2243.3:2010. In addition best practices and safe work practices described in other internationally recognised biological safety references such as the 5th edition of the Biosafety in Microbiological and Biomedical Laboratories (BMBL) and the 3rd edition of the Laboratory Biosafety Manual published by the World Health Organization (WHO), have also been considered. References give a full list of the resources that was referred to in coming up with this information.
If a laboratory has been certified by the Office of Gene Technology Regulator (OGTR) as an OGTR-certified PC2 laboratory for the handling of genetically modified organisms / materials or approved by the Department of Agriculture and Water Resources (DAWR) as a BC2 approved arrangement (AA) site for the handling of quarantined biological material then in addition to the general biosafety requirements outlined in the above links, applicable regulatory requirements must be adhered to.
These requirements are NOT covered in this section.
- Fleming D. (2006) Risk Assessment of Biological Hazards, In: Biological Safety: Principles and Practices (Fourth Edition), pp. 81-91, Fleming DO & Hunt DL (Eds.), ASM Press, Washington, DC, USA.
- Harding A and Byers K. (2006) Epidemiology of Laboratory-Associated Infections, In: Biological Safety: Principles and Practices (Fourth Edition), pp. 53-77, Fleming DO & Hunt DL (Eds.), ASM Press, Washington, DC, USA.
- Public Health Agency of Canada. Pathogen Safety Data Sheets and Risk Assessment.
- Standards Australia/Standards New Zealand. (2010). Australia (AS) / New Zealand Standard (NZS) 2243.3:2010. Safety in Laboratories - Microbiological safety and containment
- U.S. Department of Health and Human Services, Public Health Service, Centers for Disease Control and Prevention & National Institutes of Health, USA. (2009). Biosafety in Microbiological and Biomedical Laboratories (BMBL), 5th edition.
- World Health Organization. (2004). Laboratory Biosafety Manual, 3rd Edition.