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This fact sheet includes general information intended for members of the public, and to anyone wishing to work with a genetically modified organism (GMO) in Australia. Prior to undertaking any work with a GMO further details should be sought from an institutional biosafety committee (IBC) or from the Office of the Gene Technology Regulator (OGTR).
In Australia, certain dealings involving a GMO require authorisation under the Gene Technology Act 2000 (the Act), the Gene Technology Regulations 2001 and corresponding State and Territory legislation.
Examples of dealings involving a GMO that may require authorisation include experimentation, breeding, propagation, manufacture, culture, import, transport and disposal. In the absence of appropriate authorisation these types of activities could be illegal and may attract criminal penalties.
Types of dealings and respective authorisation and containment requirements
Dealings regulated under the Act may pose varying levels of risk to the health and safety of people and the environment, and may therefore require different levels of authorisation and containment. In most cases an authorisation to conduct a dealing is issued by an IBC or by the Gene Technology Regulator (Regulator) following a risk assessment.
IBCs serve as an important liaison between people working with, and intending to work with, GMOs and the Regulator. All proposed dealings should initially be evaluated by an IBC
An authorisation to conduct a dealing will usually include a requirement for the GMO to be contained in a certified physical containment (PC) facility such as a laboratory, animal room or glasshouse. In order for a dealing to be undertaken in a PC facility, the facility must have certification from the Regulator. PC facilities must meet specific criteria before they can be certified by the Regulator and are inspected to ensure compliance with their conditions of certification.
The table below provides a summary of the types of dealings regulated under the Act and their respective authorisation and requirements for PC.
Exempt dealings are often used in university teaching laboratories involving basic molecular biology techniques with non-pathogenic genetically modified (GM) microorganisms that have a long history of safe use. These types of dealings involve GMOs that have been assessed as posing negligible risks to the health and safety of people and the environment and do not require approval from, or notification to, the Regulator. Nevertheless, the GMOs must not be released into the open environment.
Notifiable Low Risk Dealings (NLRDs)
NLRDs are dealings that pose minimal risk to the health and safety of people and the environment provided that they meet specified conditions. Unless otherwise authorised, NLRDs must be conducted in PC facilities that are certified by the Regulator.
NLRDs must be assessed by an IBC before any work commences, and the IBC must agree that the proposed facility is suitable for the particular NLRDs. IBCs are required to notify the Regulator annually about new NLRDs, and maintain thorough records.
Dealings Not Involving Intentional Release (DNIRs)
A person wishing to conduct a DNIR must apply to the Regulator for a licence. The Regulator must assess a DNIR application, prepare a risk assessment and risk management plan, and issue a licence if satisfied that any risks to people and the environment are able to be effectively managed by the applicant. A licence would specify conditions that minimise the risks to people working with the GMOs, the public and the environment.
DNIRs must be conducted in PC facilities, are subject to monitoring and any adverse events must be reported to the Regulator.
Much of the research authorised under DNIR licences focuses on studying human disease and seeking treatments or cures.
In 2013-14, 60%
of DNIR licences were issued to universities, 30%
to hospitals and government research institutions, and a further 10% were issued to private companies.
Dealings Involving Intentional Release (DIRs)
DIRs, which include any intentional release of a GMO into the open environment, are the most highly scrutinised category of dealings. Like DNIRs, these must be assessed and licensed by the Regulator. Before deciding whether to issue or refuse to issue a DIR licence, the Regulator must:
- conduct a rigorous scientific assessment aimed at identifying potential health risks to humans and the environment and prepare a plan for managing any risks;
- consult extensively, including with the Gene Technology Technical Advisory Committee, Minister for Environment, other Commonwealth regulatory agencies, the states and territories, and local councils;
- invite submissions from the public, including by advertising in newspapers; and
- publish the risk assessment and risk management plan on the OGTR website.
of current DIR licences are for field trials (called ‘limited and controlled releases’ in the legislation) of GM plants. These licences mandate conditions to limit the release of the GMO and to control the spread and persistence of the GMO in the environment. The remaining DIR licences are for clinical trials of GMOs or for commercial release of GM plants or GM vaccines.
The GMO Register
The GMO Register is a list of dealings with GMOs deemed sufficiently safe by the Regulator to be undertaken by anyone without the oversight of a licence holder. GMO dealings proposed for the Register must previously have been licensed and they may still be subject to conditions. To date, the only entry on the GMO Register is dealings involving GM carnations that have been modified to have blue/purple flowers. The GM carnations were first commercially released in 1996.
Inadvertent Dealings licence
The Regulator may issue an inadvertent dealings licence to a person who unintentionally comes in to possession of a GMO. The issuing of such a licence does not require the full assessment process required by other authorisations. It facilitates prompt and safe disposal of the GMO.
Emergency Dealing Determination (EDD)
In an emergency, the Minister may authorise the temporary approval of a GMO by issuing an EDD. Prior to approval, the Minister has to be advised by specified authorities that the GMO will address an identified threat. An EDD may only be authorised if the Minister is satisfied that any risks to the health and safety of people and the environment posed by the proposed dealings with the GMO can be effectively managed.
To date, only one EDD has been made – the Gene Technology (Equine Influenza Vaccine) EDD 2007. It authorised dealings with GM vaccines against equine influenza from September 2007 to September 2008.
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