Licence Conditions

January 2014

Under the Gene Technology Act 2000 (the Act), licences may be issued for:

• Dealings NOT involving Intentional Release (DNIR) of a genetically modified organism (GMO) into the environment
• Dealings involving Intentional Release (DIR) of a GMO into the environment
• inadvertent dealings.

What conditions are included in a licence?

The following statutory conditions are conditions of all GMO licences.

Licence holders informing people of obligations (Section 63 of the Act)	The licence holder must inform any person covered by the licence, to whom a particular condition of the licence applies, of the: particular condition, including any variations of it cancellation or suspension of the licence surrender of the licence.
Allowing monitoring and auditing (Section 64 of the Act)	If a person is authorised by the licence to deal with a GMO and a particular condition of the licence applies to the dealing by the person, the person must allow the Gene Technology Regulator (the Regulator), or a person authorised by the Regulator, to enter premises where the dealing is occurring to audit or monitor the dealing.
Giving additional information to the Regulator (Section 65 of the Act)	The licence holder must inform the Regulator if they become aware of: additional information as to any risks to the health and safety of people, or to the environment, associated with the dealings authorised by the licence any contraventions of the licence by a person covered by the licence or any unintended effects of the dealings authorised by the licence.

The Regulator may also impose further specific licence conditions.

For example, in field trials, which are mainly used to conduct experiments, there are specific licence conditions that limit and control the release of the GMO to minimise the chance of spread or persistence of the GMO (or its genetic material) in the environment.

This is provided for under Sections 55, 61 and 62 of the Act.

Licence conditions for DIRs vary between individual licences. A complete list of licence conditions for individual licences can be found in the current record of applications and licences for DIRs.

What implications do licence conditions have for licence holders?

The licence holder and any people covered by the licence must, at all times, only deal with the GMO as set out in the requirements, conditions and obligations of:

• the licence
• the Act
• the Gene Technology Regulations 2001
• corresponding state law¹.

Failing to comply with the conditions of a licence is an offence, as provided by Sections 34 and 35 of the Act. Licence holders must continue to comply with other Australian laws.

The licence holder and any people covered by the licence must comply with any written direction issued by the Regulator, under Section 146 of the Act².

Staff of the Office of the Gene Technology Regulator conduct routine monitoring and compliance activities to make sure that licensed dealings with GMOs comply with legislative obligations and are consistent with the object of the Act.
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¹‘Corresponding state law’ means a state or territory law that is declared by the responsible Commonwealth Government minister to correspond to the Act or the Gene Technology Regulations 2001 as part of the cooperative national legislative scheme.

²Section 146 enables directions to be issued to the licence holder, or a person covered by the licence, if there are reasonable grounds for the belief that a direction is necessary to protect the health and safety of people, or to protect the environment. Failure to comply with a direction is an offence.