Glossary of Biological Safety Committee terms

A principal investigator who has obtained approval from the UABSC to use the University-wide low-risk HSNO approval for the development of low-risk GMOs.

Approved user status will expire after three years unless renewed.

These experiments are the lowest risk category and are defined as:

• Genetic modifications using cell lines and microorganisms that are unable to cause disease, and in which the nucleic acid insert will not impart any hazardous properties to the construct.

These experiments can be safely contained within laboratories meeting PC1 containment standards

These experiments are of moderate risk and include:

• Experiments with approved host/vector systems where the insert may be expressed as a hazardous protein
• Experiments using microorganisms or cell lines as hosts which are unlikely to be a serious hazard to laboratory personnel, the community or the environment and in which the insert is well characterised.
• Developments involving whole animals or plants

These experiments can be safely contained under PC2 containment standards.

Higher-risk GMOs are defined as organisms that do not meet the requirements of low-risk genetic modification as defined in the HSNO (Low Risk Genetic Modification) Regulations, 2003.

Examples include:

• Genetic modification using viral vectors where the inserted DNA encodes proteins known to be involved in uncontrolled cell growth
• Genetic modification with genes encoding highly toxic proteins
• Genetic modification of pathogenic hosts that cause serious human, animal or plant disease

1. Researchers are responsible for identifying the risk group of the organisms that they are working with. There is no definite list of high-risk micro-organisms, as even the risk for the same species might change according to genetic changes, use, methodology and country. The ASNZ2243.3:2022 standard provides guidance for microbial classification in Australia and New Zealand, adapting current WHO guidelines to regional requirements.
2. Any micro-organism that displays resistance to antibiotics and/or treatments used to clinically treat the micro-organism in question.

These are defined as Category A or Category B development in the HSNO (Low Risk Genetic Modification) Regulations, 2003.

A micro-organism that is unlikely to cause human or animal disease.

A micro-organism that is unlikely to be a significant risk to laboratory workers, the community, livestock, or the environment; laboratory exposures may cause infections, but effective treatment and preventive measures are available, and the risk of spread is limited.

A micro-organism that usually causes serious human or animal disease and may present 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 treatments available.

An HSNO approval (APP202708) held by the university that covers the development of a wide range of low-risk GMOs.