Summary of this Part

This Part establishes the statutory office of the Gene Technology Regulator (GTR) and specifies the GTR’s functions and powers.

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

The need for the GTR to be a strong and independent regulator has been stressed by a wide range of stakeholders. There are a number of provisions in the legislation which, when taken together, will ensure that the GTR has sufficient independence. For example, the GTR will:
  • be appointed by the Governor-General on the advice of the Commonwealth Minister for Health who must have approval for the recommendation from a majority of States and Territories;
  • report directly to Federal Parliament annually and at any other time, as required. The power to report directly to Federal Parliament on any matter is a significant power and one that is vested in a very limited number of statutory office holders;
  • manage his/her own monies as a part of a discrete fund; and
  • be responsible for making all decisions on individual applications with no political interference (refer clause 25).
Of course, independence must be balanced against accountability. It is proposed that the GTR will be accountable:
  • to the Federal Parliament (through annual reporting as detailed above); under the Financial Management and Accountability Act 1997 for the management of the “GTR’s Special Account”; and
  • to applicants, licence holders and the general public through clear, open and transparent decision-making processes.

Functions of the Gene Technology Regulator

Clause 27 sets out the functions of the GTR as follows:
  1. to perform functions in relation to GMO licences as set out in Part 5 (e.g. the licensing of GMOs);
  2. to develop draft policy principles and policy guidelines, as requested by the Ministerial Council;
  3. to develop codes of practice;
  4. to issue technical and procedural guidelines in relation to GMOs;
  5. to provide information and advice to other regulatory agencies about GMOs and GM products;
  6. to provide information and advice to the public about the regulation of GMOs;
  7. to provide advice to the Ministerial Council about:
    • the operations of the GTR and the Gene Technology Technical Advisory Committee; and
    • the effectiveness of the legislative framework for the regulation of GMOs, including in relation to possible amendments of relevant legislation.
  8. to undertake or commission research in relation to risk assessment and the biosafety of GMOs;
  9. to promote the harmonisation of risk assessments relating to GMOs and GM products by regulatory agencies;
  10. to monitor international practice in relation to the regulation of GMOs;
  11. to maintain links with international organisations that deal with the regulation of gene technology and with agencies that regulate GMOs in countries outside Australia; and
  12. such other functions as are conferred on the GTR by the Act, the regulations or any other law.

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