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ÐÓ°ÉÖ±²¥n/New Zealand Standard 2243.3 (and equivalent international standards and regulations) uses a risk group classification system to categorise microorganisms based on the degree of risk that they pose, and the level of containment required when handling the microorganisms.

There are four risk groups defined within AS/NZS 2243.3:

• Risk Group 1 – the lowest level of risk, requiring physical containment level 1
• Risk Group 2 – moderate level of risk, requiring physical containment level 2
• Risk Group 3 - high level of risk, requiring physical containment level 3
• Risk Group 4 – very high level of risk, requiring physical containment level 4

Risk group ratings apply to bacteria, viruses, parasites, fungi and prions. AS/NZS 2243.3 defines different risk group criteria for these based on their hazard to humans and animals, plants, aquatic organisms, and for microorganisms carried by invertebrate vectors.

Please refer to the ‘Microbiological Biosafety FAQs’ for further information and for definitions and examples for each risk group.

Where you are working with a microorganism that is not listed in the AS/NZS 2243.3 example tables, please contact the Research Compliance Officer: Biosafety for assistance in determining the risk group for your work.

Security Sensitive Biological Agents (SSBAs) are microorganisms and toxins deemed by the government to pose a significant risk to human health, the environment and the ÐÓ°ÉÖ±²¥n Economy if deliberately released. The use of these is controlled to limit the occurrence of acts of bioterrorism or biocrime.

Legal requirements for the SSBA scheme are established under Part 3 of the . The provide details about requirements under the scheme, and the provide detailed information on how confirmed and suspected SSBAs (and associated sensitive information) must be securely handled, stored, disposed of and transported.

The list of SSBAs is maintained by the Department of Health and Aged Care. Access the most up-to-date list on the . Note that the list refers to active toxins and infectious, viable and pathogenic organisms (i.e., excludes non-viable samples, vaccine strains and, in some cases, highly attenuated strains).

If you plan to use any SSBA on the list, have these in storage, or have received a sample suspected to contain an SSBA contact the Research Compliance Officer: Biosafety as soon as possible.

When working with biological samples, it is important to remember that pathogenic microorganisms may be present.

Where a particular microorganism is known or suspected to be present in a sample then the sample should be handled following the requirements and practices for the risk group of that microorganism.

• AS/NZS 2243.3 states that all human and animal clinical and diagnostic samples (bodily fluids, tissues, etc.) and human primary cells must be handled following Risk Group 2 precautions in Physical Containment Level 2 facilities, unless a higher level of risk is indicated.
• For diagnostic samples suspected to contain a Security Sensitive Biological Agent (SSBA), then requirements under the also apply. See ‘Security Sensitive Biological Agents’ for further information.
• For human respiratory or faecal samples, you must also consider whether the samples are Poliovirus Potentially Infectious Materials (PIMs) as described in the . See ‘Poliovirus Potentially Infectious Materials FAQs’ for further information.

In cases where the microbiological risk of a biological sample is unknown, then the samples must be handled following standard precautions.

Standard precautions are the minimum infection control measures that everyone handling unfixed biological samples should follow when the risk rating of the sample is not otherwise indicated (see ‘Microbiological Risk Groups’ and ‘±«²Ô°ì²Ô´Ç·É²ÔÌýBiological Hazards’ for further information on risk ratings of biological samples).

Standard precautions include:

• Using aseptic techniques.
• Washing or sanitising hands after handling samples.
• Using ‘barrier protection’ (e.g., a water-proof Band-Aid and disposable latex or nitrile gloves) over any open cuts, scrapes or sores.
• Use of personal protective equipment as indicated by risk assessment. Enclosed shoes and a long-sleeved lab coat or gown must always be worn.
• Practicing sharps safety techniques.
• Cleaning and disinfection of work surfaces and contaminated equipment after use.
• Safe waste management.
• Receiving vaccinations as recommended by your health care professional and the ÐÓ°ÉÖ±²¥n Immunisation Handbook.

1. Requirement for containment

Research and teaching involving:

• viable microorganisms.
• human primary cells.
• human and animal clinical specimens.

must be undertaken in a microbiological physical containment facility. The type and level of containment facility required is dictated by the risk group of the microorganism(s) and the nature of work undertaken (see ‘Microbiological Risk Groups’ and ‘Containment Facilities’ for further information).

2. Requirement for risk assessment and (where applicable) applications

All work involving microorganisms, human or animal samples and biological samples with unknown microbiological content must be risk assessed.

For the following specific categories of work, a microbiological risk application must be completed and submitted to the IBC for assessment prior to work commencing:

• Work with viable risk group 2 microorganisms, including bacteria, viruses, parasites, fungi, algae, or prions, that may cause disease in, or are pathogenic, allergenic, or toxic to humans, animals, plants, or aquatic organisms.
• Isolation or culture of microorganisms from human or animal bodily fluids or tissues.
• Work with animals or plants knowingly infected with a microorganism capable of causing disease.
• Work with primary cells or cell lines that are known or reasonably suspected to contain risk group 2 microorganisms.
• Isolation, culture, or enrichment of unknown microorganisms from environmental samples where the methods used are designed or intended to isolate, culture or enrich risk group 2 (or higher) microorganisms.
• Storage of risk group 2 microorganisms or samples known to contain these.

3. Risk group 3 and 4 microorganisms and SSBAs

As the ÐÓ°ÉÖ±²¥ does not have any Physical Containment Level 3 or 4 facilities, or any facilities registered for work with Security Sensitive Biological Agents, you must contact the IBC prior to planning either of the following:

• Work with or storage of Security Sensitive Biological Agents and samples containing these.
• Work with or storage of viable or non-viable risk group 3 or 4 microorganisms, including in animals, plants or samples.

Note that in many cases, you will be unable to receive, handle or store samples falling under these higher risk categories at the ÐÓ°ÉÖ±²¥ as we do not have containment facilities suitable for this level of work.

A risk assessment must be undertaken prior to commencement of any work with risk group 2 or higher microorganisms, or work with infectious or potentially infectious samples. Information on the types of risk assessments that must be submitted to the IBC is available under part 2 of 'What requirements apply' on this page.

When undertaking a risk assessment for work with microorganisms or samples containing microorganisms, you must consider factors about the nature of the microorganism, the methods being undertaken, and how the two may affect each other.

1. Consider the risks inherent to the microorganism or sample – e.g., viability and environmental stability, method of dissemination and transmission, endemic nature, host range, likelihood and severity of disease in susceptible individuals. For samples, an understanding that microorganisms are likely to be present is important.
2. Consider the risks of the methods you are undertaking, and the potential for those methods to lead to infection of a susceptible host – e.g., potential for generation of aerosols or droplets, volume and concentration, potential for cross-contamination.
3. Classify the risk group based on the characteristics of the microorganism and consider whether the work you are undertaking increases the risk.
   • E.g., in AS/NZS 2243.3, work with patient specimens containing SARS-CoV-2 is classified as risk group 2, suitable for a PC2 laboratory, but isolation and culture of the virus is risk group 3 and requires PC3 containment because the risk of the work increases the likelihood of infection and detrimental outcomes.
4. Consider any regulatory conditions that may apply to the microorganisms (e.g., import conditions, SSBA requirements, PIRSA or SA Health requirements).
5. Consider the training and experience level of personnel involved in the work.
6. Identify the required level of containment and risk controls to manage known risks.
7. Review and revise periodically, and in the event of any incident, injury or illness.

The ÐÓ°ÉÖ±²¥ of Adelaide Institutional Biosafety Committee (IBC) acts as a Biosafety Committee as defined within AS/NZS 2243.3. The IBC is responsible for the following actions with regards to microbiological biosafety:

• Providing advice, guidance and training materials for personnel in relation to microbiological biosafety.
• Overall monitoring and surveillance of the continuing implementation of standards and guidelines.
• Review of risk assessments before work commences and considering the implications of microbiological components of research proposals.
• Inspections of microbiological containment facilities and any licencing of laboratories for microbiological work.