Risk Assessment and Risk Management Plan Application for licence for dealings involving intentional release of a genetically modified organism into the environment dir 034/2003 Title: Field Trial of Genetically Modified Cotton



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Section 6 Decision On Licence


  1. Having taken the required steps for assessment of a licence application, the Regulator must decide whether to issue or refuse a licence (Section 55 of the Act). The Regulator must not issue the licence unless the Regulator is satisfied that any risks posed by the dealings proposed to be authorised by the licence are able to be managed in such a way as to protect the health and safety of people and the environment.

  2. The Regulator must also have regard to any policy guidelines issued by the Ministerial Council that relate to risks to human health and safety and the environment, or the management of such risks. At this time no policy guidelines have been issued.

  3. The Regulator also must not issue a licence if this would be inconsistent with a policy principle issued by the Ministerial Council. The Gene Technology Ministerial Council recently agreed a policy principle "Gene Technology (Recognition of Designated Areas) Principle 2003" (the Principle), which allows for recognition of GM or non-GM designated areas for marketing purposes. The Principle is designed to ensure the valid operation of State and Territory laws declaring areas to be GM, non-GM or both for marketing purposes.

  4. The Regulator must also be satisfied, under section 57 of the Act that the applicant is a suitable person to hold the licence. Section 58 outlines matters the Regulator must consider in deciding whether a person or company is suitable to hold a licence eg.:

  • any relevant convictions;

  • any relevent revocations or suspensions of a licences or permits; and

  • the capacity of the person or company to meet the conditions of the licence.

  1. The Regulator carefully considers all of this information which is supplied in a declaration signed by licence applicants.

  2. The Monitoring and Compliance Section of the OGTR compiles compliance histories of applicants, considering all previous approvals to deal with GMOs under the Act and the previous voluntary system. These histories as well as other information such as follow-up actions from audits may be taken into account. The ability of an organisation to provide resources to adequately meet monitoring and compliance requirements may also be taken into account.

  3. If a licence is issued, the Regulator may impose licence conditions (Section 62 of the Act). For example, conditions may be imposed to:

  • limit the scope of the dealings;

  • require documentation and record-keeping;

  • require a level of containment;

  • specify waste disposal methods;

  • manage risks posed to the health and safety of people, or to the environment;

  • require data collection, including studies to be conducted;

  • limit the geographic area in which the dealings may occur;

  • limit the dissemination or persistence of the GMO or its genetic material in the environment; and

  • require contingency planning in respect of unintended effects of the dealings.




  1. It is also required as a condition of a licence that the licence holder inform any person covered by the licence of any condition of the licence which applies to them (Section 63). Access to the site of a dealing must also be provided to persons authorised by the regulator for the purpose of auditing and monitoring the dealing and compliance with other licence conditions (Section 64 of the Act). It is a condition of any licence that the licence holder inform the Regulator of:

  • any new 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; and

  • any unintended effects of the dealings authorised by the licence.

It should be noted that, as well as imposing licence conditions, the Regulator has additional options for risk management. The Regulator has the legislative capacity to enforce compliance with licence conditions, and indeed, to direct a licence holder to take any steps the Regulator deems necessary to protect the health and safety of people or the environment. The OGTR also independently monitors trial sites to determine whether the licence holder is complying with the licence conditions, or whether there are any unforseen problems.APPENDIX 9 Summary of public submissions



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