Summary of this Part

Part 9 of the Bill provides for various administrative matters relating to the appointment and conditions of the GTR, financial matters and matters relating to staff.

Some of the provisions are technical provisions which will support the smooth operation of the legislation. Other provisions have been inserted to guarantee the independence and accountability of the GTR. For example:
  • the GTR may make reports directly to Parliament;
  • the GTR must report annually to Parliament;
  • a Gene Technology Account is established for which the GTR is responsible; and
  • the GTR is appointed by the Governor-General following agreement by a majority of State and Commonwealth Ministers.
Part 9 also establishes the Record of GMOs and GM product dealings, and provides for the review of notifiable low risk dealings and exemptions described in the regulations.

Key provisions in this Part and major changes as a result of consultation on the draft Bill

Appointment and conditions of the GTR (Division 2).

This Division provides that the GTR:
  • must be appointed by the Governor-General, who is advised by the Commonwealth Minister for Health. In turn, the Minister for Health will be advised by the Gene Technology Ministerial Council. Before advising the Governor-General, the Health Minister must be satisfied that a majority of State and Territory Ministers support the appointment. As this is a national scheme, it is important that all jurisdictions have input into the decision regarding the person who will administer the legislation on behalf of all jurisdictions. This process is also important for ensuring the independence of the GTR;
  • holds office for terms of not less than 3 years or more than 5 years, although the GTR may be re-appointed;
  • may have his/her appointment terminated by the Governor-General on specified grounds. The grounds for termination described in the legislation are consistent with Commonwealth Government policy and with termination provisions prescribed for other statutory office holders; and
  • must give written notice to the Minister of all financial or other interests that the GTR has or acquires that could conflict with the proper performance of the GTR’s functions under the Bill and regulations.
The Division also sets out procedures for acting appointments and how the terms, conditions and remuneration of the GTR will be determined.

Money (Division 3)

This Division provides that the GTR may charge for services provided by the GTR in the performance of the GTR’s functions and establishes a special Gene Technology Account.

The establishment of a discrete account to be administered by the GTR in the performance of his/her functions provides another level of independence to the GTR. Rather than the GTR’s monies being part of a Departmental appropriation, they will be quite discrete; the GTR will be solely responsible for the administration of the Gene Technology Account.

Monies which must be credited to the Gene Technology Account include:
  • monies appropriated by the Parliament for the GTR;
  • amounts equal to amounts received by the Commonwealth under the Gene Technology (Licence Charges) Act 2000;
  • amounts equal to fees received by the Commonwealth by way of licence application fees and fees associated with applications for certification of facilities;
  • amounts equal to amounts received by the Commonwealth in connection with the performance of the GTR’s functions; and
  • amounts recovered by the Commonwealth as the result of the GTR recovering costs associated with a remediation exercise.

Staffing (Division 4)

This Division provides that:
  • the staff necessary to assist the GTR are to be made available by the Secretary of the Department of Health. This means that the GTR will recruit staff to ensure that he/she attracts suitably skilled and qualified employees but once selected the staff will be employed under the certified agreement of the relevant Departmental Secretary with their positions being funded by the GTR;
  • the GTR may engage consultants - on terms determined by the GTR – to assist in carrying out the functions of the office; and
  • the GTR may be assisted by Commonwealth public servants and officers of Commonwealth authorities and officers of State Departments and authorities made available to the GTR to assist with the performance of his/her functions.

Reporting Requirements (Division 5)

This Division provides that the GTR:
  • must report annually to the Commonwealth Minister for Health, who must table the report in Parliament. The report must also be provided to the responsible Minister in each State and Territory and posted on the GTR’s website;
  • may make a report to Federal Parliament on any matter relating to the GTR’s functions. For example, the GTR may wish to make a report in relation to a very serious breach of the legislation by a particular licence holder, or to report on some other urgent matter. This is a significant power that is rarely bestowed on statutory office holders. The Chief Executive Officer of the Australian Radiation Protection and Nuclear Safety Agency is one of the few statutory office holders with such a power.
Consistent with the IOGTR’s commitment to report quarterly during the interim arrangements (before this legislative scheme takes effect), the GTR will also make public reports quarterly.

Record of GMO and GM Product Dealings (Division 6)

During consultations, stakeholders supported the involvement of the public at various stages in the decision-making process for individual licence applications (as is reflected in Part 5 of the Bill). They also expressed the need for information about the final approval to be made available to “complete the feedback loop” and provide for maximum accountability and transparency.

This Division requires the GTR to keep a publicly available “Record of GMO and GM Product Dealings” (to be known as ‘the Record’).

The Record will include information (excluding confidential commercial information) about:
  • all licences granted by the GTR, including the name of the licence holder, the persons covered by the licence, the dealings authorised by the licence and the GMO to which those dealings relate and any licence conditions;
  • notifiable low risk dealings notified to the GTR;
  • GM products approved by other regulators such as the National Registration Authority (for GM agricultural and veterinary chemicals), the Therapeutic Goods Administration (for GM therapeutics), the National Industrial Chemicals Notification and Assessment Scheme (for GM industrial chemicals) and the Australia New Zealand Food Authority (for GM foods).
The Record will be available on the GTR’s website and members of the public may also request extracts of the Record from the GTR. The public will have ready access to information about all GMOs and GM products being used in Australia.

Reviews of notifiable low risk dealings and exemptions (Division 7)

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As detailed in Part 6 of the Bill, notifiable low risk dealings and exempt dealings will be described in regulations made under the Bill.

Recognising that the technology is changing very rapidly, it is important to regularly review the GMOs and dealings prescribed as notifiable low risk dealings and exempt dealings. This will keep notifiable low risk dealings and exemptions up to date with the latest scientific developments and information regarding any risks. It is equally important that the community (including the research community) be able to input into this process.

This Division therefore sets out a process for the GTR to:
  • undertake a review of the dealings with those GMOs which have been included in the regulations as notifiable low risk dealings or exempt dealings; publish a notice inviting written submissions on whether certain dealings should remain on (or be added to) the list of notifiable low risk dealings and exemptions; and
  • make recommendations to the Ministerial Council, following a review, that the regulations be amended to either add new dealings with GMOs to the schedules of notifiable low risk dealings and exemptions or remove current entries from the schedules.
Provisions describing this review process were not included in the consultation draft of the Bill. The suggestion that review processes were needed for notifiable low risk dealings and exemptions included in the Bill was made by a member of the public during consultations, and was then canvassed at subsequent consultations. As the suggestion was favorably received at those consultations, review provisions were included in the draft Bill.

For a clause by clause explanation of this Part please refer to the Explanatory Memorandum to the Gene
Technology Bill 2000