Gene Technology Practices

In Australia, the regulation of GMOs and certification of associated facilities is performed by the Office of the Gene Technology Regulator (OGTR). The OGTR provides a framework for risk management and assessment when dealing with GMOs, which we implemented to ensure safety in our project. All students completed an Introduction to Gene Technology Practices Tier 2 module mandatory for those working in Office of Gene Technology Regulator certified facilities, including the PC2 facility where we conducted our research. This module is aimed at providing a guide for the identification and assessment of WHS requirements while working with GMOs in an OGTR certified facility. Students were provided with an introduction to the structure of gene technology regulation in Australia, types of dealings (accreditation, licensing), and PC requirements.

Under the order of the OGTR and iGEM No Release Policy, no engineered organisms will be intentionally released outside the laboratory during our project. However, our ultimate goal, the application of GMO coral probiotics for ROS neutralisation in the native coral biofilm during bleaching events, would necessitate GMO release. If our project developed to this stage, additional safety and ethical risks would need to be considered. To allow release into the environment, we would require a Dealing with Intentional Release (DIR) licence, which is administered by the OGTR. Obtaining a licence would require us to perform testing to ensure GMOs do not have unprecedented adverse impacts on coral and the local marine environment. Furthermore, we would need to have implemented and demonstrated the efficacy of a reliable kill switch mechanism.

Organisms and Parts

A pathogen is an infectious agent capable of causing disease in humans, plants or animals. The OGTR divides pathogens into four different Pathogenic Risk Groups based on the risk they pose to individuals and the environment, with higher-numbered groups posing a greater hazard. The chassis used in our project was non-pathogenic Escherchia coli. According to the OGTR, this is a Risk Group 1 organism, meaning it poses a low risk to individuals and the environment, and is unlikely to cause disease. This risk was further mitigated through adherence to safety procedures including the use of appropriate PPE, training, and supervision.

Laboratory Safety

Physical containment (PC) facilities are facilities designed through a combination of building, engineering, equipment and practices for the safe handling of infectious microorganisms. These facilities are strictly controlled to ensure they can only be accessed by property trained, authorised personnel. The OGTR requires facilities to meet particular standards for PC certification. Facilities are classed into four levels, The type of work being undertaken and the risk group of microorganisms used determines the level of PC certification that is required. The higher the risk, the greater the required PC level. PC1 facilities can be used to perform tasks using biological agents or agents that are low risk of infection, including the Risk Group 1 E. coli that we use as a chassis. However, as the Australian National University does not have any PC1-certified facilities, experiments were carried out at the Australian National University John Curtin School of Medical Research in a PC2 lab approved under the OGTR certification 2894 (expiry 2029). PC2 facilities can be used to conduct work with organisms that present little to moderate risk of infection. PC2 safety features of the lab include:

  • Walls, floors, doors, windows, benches, furniture and other surfaces which are smooth and impermeable to water so that they are easy to decontaminate and are resistant to damage by decontamination agents
  • Open spaces between and under benches, cabinets and equipment accessible for decontamination
  • Dedicated wash-basin with hands-free operation taps for hand decontamination
  • Class II biological safety cabinet to contain aerosols containing Risk Group 2 GM microorganisms installed in accordance with requirements of AS 2252.4
  • Backflow prevention for water supplied to the facility (?)
  • Designated storage for personal protective equipment
  • Plumbed eyewash station