Licence Conditions
Conditions that apply to all DNIR and DIR licences
What conditions are included in a licence?
Under the Gene Technology Act 2000 ( the Act), licences may be issued for Dealings NOT involving Intentional Release (DNIR) of a GMO into the environement, Dealings involving Intentional Release (DIR) of a GMO or Inadvertent Dealings.The following statutory conditions that apply to all GMO licences. These are set out in Sections 63, 64 and 65 of the Act):
| Statutory Conditions | Relevant Section of the Act | |
|---|---|---|
| Informing people of obligations | It is a condition of a licence that the licence holder inform any person covered by the licence, to whom a particular condition of the licence applies, of the following:
|
63 |
| Monitoring and auditing | It is a condition of a licence that if:
|
64 |
| Additional information to be given to the Regulator | It is a condition of a licence that the licence holder inform the Regulator if he or she:
|
65 |
The Gene Technology Regulator (the Regulator) may also impose further specific conditions tailored to the individual GMO dealings when issuing a licence under sections 55, 61 and 62, of the Act. For example, limited and controlled DIRs, for which the principal purpose is to conduct experiments, are subject to specific licence conditions to limit and control the release thereby minimising the chance of spread or persistence of the GMO or its genetic material in the environment.
The licence conditions for DIRs vary and it is recommended that anyone seeking information about DIR licences consult the individual licences.
What implications do licence conditions have for licence holders?
- The licence holder and any persons covered by the licence must, at all times, only deal with the GMO in accordance with the requirements, conditions and obligations in the following instruments, as they exist from time to time:
- the Gene Technology Act 2000 (the Act);
- the Gene Technology Regulations 2001 (the Regulations);
- corresponding State law*;
- the licence.
* '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 Regulations as part of the co-operative national legislative scheme.
Sections 34 and 35 of the Act provide that failure to comply with the conditions of a licence is an offence.
Licence holders must continue to comply with other Australian laws. - The licence holder and any persons covered by the licence must comply with any written direction issued by the Regulator, under section 146 of the Act.
Section 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.
Staff of the Office of the Gene Technology Regulator conduct routine monitoring and compliance activities to ensure that licensed dealings with GMOs comply with legislative obligations and are consistent with the object of the Act.