Summary of this Part
This Part is one of the most critical in the Bill – it sets up the licensing system and explains how a person can apply to the GTR for a licence authorising certain dealings with GMOs. The Part has been divided into a number of Divisions that aim to walk the reader through the various stages of the licensing process.
The Part sets out the processes to be followed when the GTR is assessing applications involving two kinds of dealings:
- those that involve the intentional release of a GMO into the environment; and
- those that do not involve the intentional release of a GMO into the environment.
Key provisions in this Part and major changes as a result of consultation on the draft Bill
During consultations, the majority of stakeholders strongly supported the current GMAC system and the results GMAC has achieved in its assessment of applications for contained research work. They supported the clarity of the guidelines and the efficiency and timeliness of advice from GMAC. It is also worth noting that some stakeholders have expressed views which were more critical of GMAC. In drafting the Bill, we have worked to build on the strengths of the GMAC system in relation to contained work.
Stakeholders expressed somewhat different views with respect to applications involving the releases of GMOs into the environment. Here, stakeholders strongly expressed the importance of enhancing GMAC processes to provide a system for the regulation of such dealings which:
- is open and transparent;
- draws on a range of advice from scientific experts,
- government agencies and others;
- is open to public input into decision making;
- is based on objective scientific risk assessment; and
- takes into account broader issues such as ethical issues.
In summary, the licensing process is as follows:
An applicant applies for a licence to deal with a GMO and includes all of the supporting information which is requested by the GTR.
(b) Initial Screening
The GTR undertakes an initial screening of the application before accepting the application. This initial screening would check to ensure that all of the information requested has been provided and that the application is not inconsistent with policy principles issued by the Ministerial Council (including ethical principles). If the application does not contain the necessary information or is inconsistent with a policy principle, the GTR is not required to consider the application.
(c) If the application does not involve an intentional release of a GMO into the environment (e.g. research undertaken in a contained laboratory):
The GTR assesses the application and prepares a risk assessment and risk management plan. In preparing the risk assessment and risk management plan, the GTR may seek the advice of the scientific committee, State, Territory and Commonwealth agencies, local councils and any other person depending on the complexity of the application to undertake contained work.
This process essentially reflects the current practice in relation to applications for contained work. The GMAC Secretariat currently receives approximately 300-350 applications per year which detail proposals for contained work. Some of these applications are relatively routine and can essentially be determined by the Secretariat. Others raise more complex issues and, in those cases, advice is required from GMAC. Similarly, under the new system it is anticipated that the technical scientific staff within the GTR’s office will be able to advise the GTR on simple applications with assistance from the scientific committee without other advice being necessary.
(d) If the application does involve an intentional release of a GMO into the environment (e.g. a field trial or a commercial release of a GMO):
- Consultation on application
Where the application relates to a proposed intentional release of a GMO into the environment, the GTR must consult the scientific committee, State, Territories and Commonwealth agencies, the Commonwealth Environment Minister and local councils in making his/her assessment.
In addition, where the GTR is satisfied (from a preliminary examination of the application) that the application may pose significant risks, the GTR must also publicly notify receipt of the application in the gazette and newspapers, and call for public submissions about the risks posed by the dealing.
- Preparation of a risk assessment and risk management plan
Using all of the information that the GTR receives in written submissions from the public and advice from the scientific committee and others, the GTR must prepare a comprehensive risk assessment and risk management plan.
The risk assessment will include a risk analysis and a risk evaluation. It will:
- identify any hazards to public health and safety or the environment which are associated with the dealing, based on objective information;
- estimate the probabilities of hazards occurring;
- and estimate the risk that is a function of the above two factors.
In some cases the risks will be sufficiently great that refusing the work to proceed will be the only measure that can appropriately manage the risk. In other cases, containment, use of barriers and other mechanisms will be appropriate to manage the risk. In other cases, there may be no risks that require management.
The GTR may also do anything else necessary to inform himself/herself of any risks posed by the proposed dealings with the GMO. For example, the GTR may call public hearings, commission independent research, undertake literature reviews, and consult international experts.
- Public notification of risk assessment and risk management plans
Once the GTR has completed his/her risk assessment and risk management plan, the GTR must notify the public that a risk assessment and risk management plan (the draft determination) has been prepared and seek input on the document. The GTR must call for submissions on the assessment and plan through advertisement in newspapers, the Government Gazette and the IOGTR website. The GTR would also direct-mail all persons who registered with the GTR to receive information. The GTR must also seek input on the draft plan from the scientific committee, States and Territories and relevant Commonwealth agencies, the Commonwealth Environment Minister and relevant local councils.
(e) Matters to be taken into account in making a decision
After taking all the necessary steps, the GTR must make a decision on the application. The GTR must not issue a licence unless he/she is satisfied that any risks posed by dealings to be authorised can be managed in a way which protects public health and safety and the environment. In addition the GTR must not issue a licence:
- if the issuing of a licence is inconsistent with a policy principle issued by the Ministerial Council; and
- unless the GTR is satisfied that the applicant is a suitable person to hold a licence. In assessing the suitability of the applicant, the GTR looks at any relevant convictions of the person, any revocation or suspension of relevant permits or licences issued under a law of the Commonwealth, a State or a foreign country and the capacity of the person to meet any proposed licence conditions.
- cover a range of dealings (e.g. growing, harvesting, transporting and selling a GM crop);
- cover a number of people (e.g. the GMO seed manufacturer, the seed seller and the farmer); and
- apply conditions on any, or all, of the dealings by various people.
Licences issued by the GTR may be subject to four different types of conditions. These are conditions:
- set out in the Act - there are currently three such conditions described in clauses 63, 64 and 65 These statutory conditions require all licence holders to:
- inform anyone covered by a licence of the conditions that relate to them. This is a minimum requirement. Conditions applied on a case-by-case basis may set out exactly how such people are to be informed (e.g. through labelling, training etc.);
- allow the GTR, or a person authorised by the GTR, to enter premises for the purposes of auditing and monitoring;
- inform the GTR of any additional information that becomes available regarding risks to public health and safety and the environment or contraventions of the legislation;
- prescribed by the regulations;
- imposed by the GTR at the time of issuing the licence. The GTR may impose any conditions that are necessary to manage risk, as assessed on a case-by-case basis. The GTR may limit where the GMO is used, who uses the GMO and how it is used. For example, the GTR may require specific containment measures, waste disposal methods and reporting requirements; and
- imposed by the GTR after the licence is issued.
Once the GTR has made a decision on the licence application, the details of the licence approval will be entered on a publicly accessible Record of GMOs and GM product dealings. The Record is described in more detail in Part 9.
For a clause by clause explanation of this Part please refer to the Explanatory Memorandum to the Gene Technology Bill 2000
Decision tree for potential applicants to the Gene Technology Regulator