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January 2014

The Australian gene technology regulatory system and intersection with other regulatory agencies


Making and working with genetically modified organisms (GMOs) in Australia is regulated through a nationally consistent legal scheme, including the Commonwealth Gene Technology Act 2000 (the Act), the Gene Technology Regulations 2001 and corresponding state laws.

The object of the legislation is to protect the health and safety of people, and to protect the environment, by identifying risks posed by or as a result of gene technology and by managing those risks through regulating certain dealings with GMOs.

In Australia, dealing with GMOs is prohibited by law unless the dealing is either:
  • licensed by the Gene Technology Regulator
  • approved as a Notifiable Low Risk Dealing
  • classed as an Exempt Dealing
  • included on the GMO Register or
  • specified in an Emergency Dealing Determination.
Each state and territory can also pass its own laws regarding trade and marketing of GMOs.

How do the gene technology laws work?


The gene technology regulatory scheme is implemented and overseen by the Legislative and Governance Forum on Gene Technology (formerly the Gene Technology Ministerial Council), which has representation from the Commonwealth and each state and territory.

An integrated legislative framework establishes a number of regulatory authorities with complementary responsibilities and expertise. This arrangement improves coordinated decision-making and avoids duplication.

Who makes the decisions?


The legislative framework also establishes the Gene Technology Regulator (the Regulator), who makes decisions on dealings with live and viable GMOs in Australia.

The Regulator is an independent statutory office holder who administers the Act and has extensive powers to monitor and enforce the legislation.

The Regulator will not issue a licence for someone to deal with a GMO unless they are satisfied that any risks posed by the dealing can be managed so that the health and safety of people and the environment are protected.

Openness and transparency are built into the regulatory system.

The laws require the Regulator to:
  • maintain a publicly accessible record of GMO and GM product dealings
  • give quarterly and annual reports to the Australian Parliament
  • consult the public and a wide range of experts, agencies and authorities about applications involving the intentional release of GMOs into the environment.

Which agencies have a role in regulating gene technology?


The arrangements established by the integrated legislative framework are shown below.


Agency
What they regulate
More about their role
OGTR
Office of the Gene Technology Regulator (supporting the Regulator)
Dealings with GMOs1The Regulator administers the national scheme for regulating GMOs in Australia, in order to protect health and safety of people, and the environment, by identifying risks posed by or as a result of gene technology and by managing those risks by regulating certain dealings with GMOs.
TGA
Therapeutic Goods Administration
Medicines, medical devices, blood and tissues2TGA administers legislation that provides a national framework to regulate medicines, medical devices, blood and tissues in Australia—including GM and GM-derived therapeutic products—and makes sure of their quality, safety and efficacy.
FSANZ
Food Standards Australia & New Zealand
Food3FSANZ sets standards for the safety, content and labelling of food. It conducts mandatory pre-market safety assessments for food produced using gene technology.
APVMA
Australian Pesticides & Veterinary Medicines Authority
Agricultural and veterinary chemicals4APVMA operates the national system that regulates all agricultural chemicals (including those produced in, or used on, GM crops) and veterinary therapeutic products. They consider human and environmental safety, product efficacy (including insecticide and herbicide resistance) and trade issues.
NICNAS
National Industrial Chemicals Notification & Assessment Scheme
Industrial chemicals5NICNAS provides a national notification and assessment scheme to protect the health of the public, workers and the environment from the harmful effects of industrial chemicals.
DAFF Biosecurity (formerly AQIS,
Australian Quarantine & Inspection Service)
Quarantine6DAFF Biosecurity regulates all animal, plant and biological products that may pose a quarantine pest and/or disease risk if they were imported into Australia. Import permit applications must indicate the presence of GMOs or GM material and ask for the relevant authorisation under the Act.

Relevant legislation for each agency’s responsibilities includes:
  1. Gene Technology Act 2000
  2. Therapeutic Goods Act 1989
  3. Food Standards Australia New Zealand Act 1991
  4. Agricultural & Veterinary Chemicals (Code) Act 1994 and Agricultural & Veterinary Chemicals Administration Act 1994
  5. Industrial Chemicals (Notification & Assessment) Act 1989
  6. Quarantine Act 1908 and Imported Food Control Act 1992
Contact the Office of the Gene Technology Regulator.