Table of Contents
- Definition of a microorganism
- Approach to working with microorganisms
- Classification of microorganisms - Risk Groups
- Classification of laboratories
- Security Sensitive Biological Agents (SSBA's)
A living organism (such as a bacteria, fungi or virus), too small to be seen by the naked eye but visible under the microscope.
The basic approach to working with microorganisms is to regard them all as potential pathogens and to handle them with standard microbiological techniques to minimise the risk to laboratory staff and the environment.
AS 2243.3:2010 Safety in Laboratories Part 3: Microbiological safety and containment outlines requirements for laboratories handling microorganisms. The Standard specifies different containment requirements for facilities depending on the type of microorganisms being handled. A complete copy of the Standard can be accessed via the University Library database under Standards Australia. Compliance with the relevant sections of AS/NZS 2243.3 is considered as a minimum requirement for anyone handling microrganisms.
The World Health Organisation (WHO) suggests each country draw up risk groups according to the microorganisms encountered within its boundaries. The following classification has been drawn up for Australia and New Zealand and is based on the pathogenicity of the agent, the mode of transmission and host range of the agent, the availability of effective preventive measures, and the availability of effective treatment.
a) Risk Group 1 (low individual and community risk) – a microorganism that is unlikely to cause human, plant or animal disease.
b) Risk Group 2 (moderate individual risk, limited community risk) – a microorganism that is unlikely to be a significant risk to laboratory workers, the community, livestock or the environment; laboratory exposures may cause infection, but effective treatment and preventive measures are available, and the risk of spread is limited.
c) Risk Group 3 (high individual risk, limited to moderate community risk) – a microorganism that usually causes serious human or animal disease and may present a serious a significant risk to laboratory workers. It could present a limited to moderate risk if spread in the community or the environment, but there are usually effective preventive measures or treatment available
d) Risk Group 4 (high individual and community risk) – a microorganism that usually produces life-threatening human or animal disease, represents a significant risk to laboratory workers and may be readily transmissible from one individual to another. Effective treatment and preventive measures are not usually available.
A list of examples of organisms classified into their Risk Group is provided in AS2243.3. The list includes examples of bacteria, fungi, viruses and prions.
A complete copy of the Standard can be accessed via the University Library database under Standards Australia. Pages 25-34 of the Standard provide listings of organisms into their Risk Group.
AS2243.3 specifies four levels of physical containment for laboratories.
PHYSICAL CONTAINMENT LEVEL 1 (PC1)
A Physical Containment Level 1 laboratory is suitable for work with microorganisms where the hazard levels are low, and where laboratory or facility personnel can be adequately protected by standard laboratory practice. The organisms used should generally be classified as Risk Group 1. Specimens that have been inactivated or fixed may be handled in PC1 facilities.
There is no formal certification procedure required for PC1 facilities where Risk Group 1 microorganisms are handled. Facilities must comply with the requirements for the relevant type of PC1 facility as described in AS/NZS 2243.3
PC1 Laboratory Containment Facility (pg 38-42)
PC1 Animal Containment Facility (pg 55-59)
PC1 Plant Containment Facility (pg 75-76)
PC1 Invertebrate Facilty (pg 90-91)
Please note that there is a formal PC1 certification procedure for facilities undertaking certain types of gene technology work. Click here for details.
PHYSICAL CONTAINMENT LEVEL 2 (PC2)
A Physical Containment Level 2 laboratory is suitable for work with material likely to contain microorganisms that are classified as Risk Group 2 microorganisms. If working with specimens containing microorganisms transmissible by the respiratory route or if the work produces a significant risk to humans or the environment from the production of infectious aerosols, a biological safety cabinet must be used.
There is no formal certification procedure required for PC2 facilities where Risk Group 2 microorganisms are handled. Facilities must comply with the requirements for the relevant type of PC2 facility as described in AS/NZS 2243.3.
PC2 Laboratory Containment Facility (pg 40-44)
PC2 Animal Containment Facility (pg 60-63)
PC2 Plant Containment Facility (pg 76-79)
PC2 Invertebrate Facilty (pg 92-95)
Please note that there is a formal PC2 certification procedure for facilities undertaking certain types of gene technology work. Click here for details.
In any facility where Risk Group 2 microorganisms are handled a “PC2 Microbiological Laboratory” sign must be displayed on the entrance door to the facility. Click here for an example of suitable signage. Alternatively you should be able to purchase signage from a laboratory supply company.
The “PC2 Microbiological Laboratory” signage is completely separate from OGTR PC2 signage which designates that approved work with genetically modified organisms is undertaken in the facility. Some facilities will require both forms of signage, while some will only require one or the other. It depends on the nature of the work being undertaken. Click here for information on signage requirements for OGTR certified facilities.
PHYSICAL CONTAINMENT LEVEL 3 (PC3)
A Physical Containment Level 3 laboratory is suitable for work with carried out with microorganisms or material likely to contain microorganisms that are classified as Risk Group 3 microorganisms.
A PC3 laboratory or facility provides additional building features and services to minimise the risk of infection to individuals, the community and the environment.
The University currently has no PC3 facilities. Anyone intending to handle Risk Group 3 organisms and therefore requiring a PC3 facility should contact the University’s Biosafety Advisor for advice.
PHYSICAL CONTAINMENT LEVEL 4 (PC4)
A Physical Containment Level 4 laboratory is suitable for work with microorganisms classified as Risk Group 4 microorganisms. A PC4 laboratory or facility is situated in a building separate from other laboratories facilities or constructed as an isolated area within a building.
The University has no PC4 facilities. Anyone intending to handle Risk Group 4 organisms and therefore requiring a PC4 facility should contact the University’s Biosafety Advisor for advice.
AS/NZS 2243.3:2010 Safety in laboratories Part 3: Microbiological safety and containment
The Security Sensitive Biological Agents (SSBA) Regulatory Scheme which includes
- The National Health Security Act 2007
- The National Health Security Regulations 2008
- The Security Sensitive Biological Agent (SSBA) Standards
was implemented in 2009 to improve the security of biological agents of security concern in Australia. The scheme regulates dealings (including receiving, holding, using and storing) of specific biological agents.
A two-tiered list of security-sensitive biological agents (SSBA's) has been established with the regulation of Tier 1 organisms commencing on the 31 January 2009 and the regulation of Tier 2 organisms commencing on the 31 January 2010.
Individuals are in breach of the The Security Sensitive Biological Agents (SSBA) Regulatory Scheme if they have not registered their individual SSBA’s by 31st January 2010 with the Department of Health and Ageing. Registration of SSBA’s requires the development of numerous documents, review of these documents by a committee, as well as requiring certain levels of security on the individual laboratory where the organisms are stored or used.
Further information on the Regulatory Scheme can be found at http://www.health.gov.au/ssba. Of particular note is the Security Risk Template which has been developed as a checklist for entities and facilities to use after completing a security risk assessment to ensure all risks have been identified and treated. The Security Risk Template can be used as a mechanism to check for compliance with the SSBA Standards.
Anyone with holdings of Tier 1 or Tier 2 organisms must contact Jenny Thomson (Biosafety Advisor) as soon as possible to discuss measures that need to be taken to ensure compliance.