Summary of this Part

This Part achieves three main objectives. It:
  • sets out the definitions used in the Act - these definitions determine the meaning of certain words whenever they are used in the Bill. The definitions define the scope of the legislation;
  • sets out the formal mechanical provisions, which enable the legislation to operate as part of a national scheme in conjunction with State and Territory legislation;
  • describes how policy principles, policy guidelines and codes of practice must be developed under the legislation by the Ministerial Council.

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

Definitions (Division 2)

During consultations on the draft Bill we received a lot of positive support for the definitions used in the Bill. Overall, people felt that it was important that the central definitions in the legislation (for the terms ‘genetically modified organism’, ‘gene technology’ and ‘deal with’) be drafted as broadly as possible to ensure maximum potential coverage of the legislation.

The definitions that attracted the most comment were the central definitions of “deal with”, “genetically modified organism” and “gene technology”.

Deal with, genetically modified organism and gene technology

Taken together, the effect of these definitions is that the legislation will regulate all ‘dealings’ (e.g. research, manufacture, production, commercial release and import) with:
  • organisms (that is biological entities that are viable, capable of reproduction or capable of transferring genetic material) that have been modified by gene technology. GMOs may be organisms that have been modified by any means aside from:
    • sexual reproduction;
    • homologous recombination; and
    • techniques described in regulations.
  • organisms that have inherited particular traits from an organism (the initial or parent organism) where those traits occurred in the parent organism because of gene technology. This enables the legislation to cover the progeny of GMOs where the progeny may have resulted from sexual reproduction but where the progeny continue to have traits that resulted from the gene technology of the initial or parent organism; and
  • anything declared by the regulations to be a GMO. Stakeholders have expressed the strong view that the legislation be able to respond to changes in technology and be able to cover GM products where necessary. As a general rule most GM products are regulated by existing regulators (for example, GM therapeutic goods are regulated by the TGA and GM food products are regulated by ANZFA). This capacity to declare an organism to be a GMO would enable any organisms or products that fall “into the gaps” and are not regulated by existing regulators to be regulated by the GTR. So far, very few such products have been identified – one of them is GM stockfeed.
The definition of a GMO explicitly excludes:
  • a human being - if the human being is only caught by the definition of a GMO because they have undergone somatic cell gene therapy. The first draft of the Bill defined GMO to exclude a human being (without any reference to somatic cell gene therapy). This caused a great deal of confusion because people assumed that the legislation therefore excluded any trials involving the use of GMOs in humans. On the contrary, the intent was to avoid the situation whereby a person who has undergone gene therapy becomes a GMO (because they would be an organism that has been modified by techniques of gene technology) and would then have to be licensed by the GTR. This has now been clarified.
In summary, the GTR will regulate all organisms modified by gene technology (including human cell lines, tissue samples etc). In relation to somatic cell gene therapy involving humans, the TGA and the NHMRC will have primary responsibility for overseeing any such trial, but the GTR will also be involved in order to ensure that there are no environmental risks posed by GMOs to be used as part of the human trials. A human who has undergone such somatic cell gene therapy would not, once they have completed the therapy, be considered to be a GMO under the Bill (by virtue of the exclusion in the definition of GMO described above).
  • organisms declared by the regulations not to be genetically modified organisms. It is anticipated that, from the outset, the types of organisms declared not to be GMOs would include plants derived using protoplast fusion and organisms derived using various types of mutagenesis, such as chemical mutagenesis. Again, it is important that the legislation be flexible enough to respond to changes in technology, as well as any anomalies in the application of the legislation.
The GTR as a “one stop shop

A number of stakeholders felt that the legislation should regulate all dealings with GMOs and GM products, regardless of whether they are currently regulated by an existing regulatory agency.

The legislation addresses this concern by creating a one-stop shop for biosafety assessment of all GMOs and GM products. It does this by establishing a centralised national regulator who undertakes risk assessment of all GMOs and GM products.

The Gene Technology Bill 2000 regulates all dealings with live, viable organisms that have been modified by techniques of gene technology, regardless of whether these are also examined by other regulators. However, in the case of GM products that are not live and viable, where:
  • these are not regulated by any other regulatory agency – the GTR will directly regulate those GM products (for example, stock feed);
  • these are regulated by other regulatory agencies – the regulatory agency must seek, and take into account, the GTR’s advice and must notify the GTR of the decision regarding the GM product, so that the GTR can include the information on the record of GMO and GM product dealings, the comprehensive database of GMOs and GM products approved for use in Australia.
In essence, the suggestion that the legislation should deal with all GMOs and GM products has been reflected in the Bill, as the GTR will directly regulate all GMOs and if there are products flowing from such GMOs, these products will undergo a second round of assessment by the relevant regulatory agency with advice from the GTR.

The advantages of this approach are that it:
  • recognises the roles of each of the existing regulators and the desirability of assessing GM products along with their non-GM counterparts under the relevant regulatory framework . For example, GM therapeutic goods are most appropriately assessed for safety, quality and efficacy under the therapeutic goods scheme, with advice on the safety aspects associated with the genetic modification of the pharmaceutical being provided by the GTR;
  • ensures that like products are treated in a similar way (reducing market distortions) while also ensuring that any risks posed by gene technology are considered;
  • ensures that the GTR acts as a centralised area of expertise on genetic safety and makes advice available to other regulators of GM products. This reduces costs to Government by eliminating the need for each regulatory agency to establish its own centre of expertise on gene technology;
  • ensures that all aspects of the production, manufacture and sale of GMOs and GM products (in fact, all dealings) are regulated and that there are no ‘gaps’ in regulatory coverage. The system also ensures that the GTR either directly regulates, or provides advice to other regulators, on all GMOs and GM products;
  • minimises duplication by implementing strategies to improve the interface between regulators. For example, the legislation requires:
    • exchange of information between regulators;
    • the GTR to hold a centralised database of all approvals for GMOs and GM products; and
    • the GTR to work with other agencies to harmonise data requirements, assessment and standards in relation to risks posed by gene technology.

The national scheme (Divisions 3 and 4)

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When Australian governments began to look at the options for regulating gene technology, several years ago, various alternatives were considered. For example, governments considered:
  • continuing the current voluntary arrangements;
  • enacting discrete legislation in each jurisdiction;
  • enacting Commonwealth-specific legislation; or
  • developing a nationally consistent scheme for the regulation of gene technology.
After detailed consideration, all governments strongly supported the development of a national scheme for gene technology, to be administered by a single central national regulator (the Gene Technology Regulator) responsible for managing any risks posed by GMOs to human health or the environment. This position was also strongly supported by stakeholder groups including industry, environment and consumer groups and primary producers.

Governments and stakeholders consider that a national scheme of legislation (relying on Commonwealth legislation and complementary legislation in each jurisdiction) is the only approach which:
  • ensures maximum national consistency of gene technology regulation; ensures that the legislation applies equally to all companies, research institutions, and individuals, as well as Commonwealth and State/Territory agencies in Australia;
  • provides a streamlined and certain pathway for businesses seeking approval for dealings with GMOs;
  • minimises the costs of compliance to government and business that operate in more than one jurisdiction;
  • minimises inefficiencies and distortions in the market place as the result of differing levels of regulation in different jurisdictions; and
  • minimises discrepancies between jurisdictions and potential gaps or
  • loopholes in legislative coverage that could undermine community confidence in the safe management of GMOs. The system ensures that the “lowest common denominator” does not prevail and that the regulatory approach affords the highest possible level of protection for the environment and human health.
How will the national scheme work?

The national scheme works in the following way:
  • The Commonwealth Gene Technology Bill 2000 relies on a range of constitutional powers, including the corporations power, the trade and commerce power, the quarantine power, the census and statistics power, the powers of the Parliament and the incidental power. This ensures that from the first day of operation of the national scheme there is maximum coverage of people and activities. The powers relied on to support the Commonwealth Gene Technology Bill are detailed in clause 13 of the Bill.
  • Each State and Territory will enact complementary legislation to supplement the Commonwealth legislation. Each piece of legislation will be consistent, and will empower the GTR to do all of the things set out in the Commonwealth Bill for bodies able to be constitutionally covered by the Commonwealth (e.g. corporations) and bodies and individuals able to be covered by the States (e.g. State agencies).
  • When a State or Territory enacts a law that is substantially the same as the Commonwealth law, the Commonwealth law will “wind back” so that the State law (rather than the Commonwealth law) will apply to:
    • all higher education institutions;
    • state agencies; and
    • all individuals that might have been covered as a result of the use of the quarantine power (in relation to limiting the spread of pests and diseases).
  • In combination, the Commonwealth and State legislation enables consistent application of the scheme to all individuals and organisations in Australia.
  • The fact that the GTR’s powers will be derived from a combination of Commonwealth, State and Territory legislation will have minimal effect on the day-to-day operation and administration of the scheme.

Policy principles, policy guidelines and codes of practice (Division 4, Subdivision B)

During consultations on the draft Bill, a number of stakeholders expressed concern about the way the provisions relating to policy guidelines and codes of practice issued by the Ministerial Council had been presented. They considered that:
  • it was not sufficiently clear what policy guidelines and codes of practice were;
  • while it was important that Ministers play a role in policy-setting in relation to the legislative scheme, it was equally important that the GTR’s independence be maintained. People considered that the Ministerial Council should not be able to override a decision of the GTR, which would be based on protection of health and safety and the environment, by issuing ad hoc policy guidelines (for example, on trade-related matters);
  • regulatory certainty for industry was important, so if policy principles were to be made by the Ministerial Council (and expected to be observed by the GTR and by industry) then the requirements of the policy principles should be subject to consultation, be clearly articulated and finally subjected to Parliamentary scrutiny.
On the basis of this feedback, the provisions which address the Ministerial Council’s issuing of policy documents have been redrafted, and the distinctions between policy principles, policy guidelines and codes of practice have been made clearer.

Policy principles:
  • The Ministerial Council may issue policy principles on ethical issues relating to dealings with GMOs, and on other matters prescribed in regulations. However, matters prescribed in regulations must not compromise the primary focus on the health and safety of people and the protection of the environment.
  • The policy principles must be developed in consultation with each of the committees established under the legislation, relevant Commonwealth and State agencies, industry groups and environmental, consumer and other groups.
  • Once issued by the Ministerial Council, the policy principles will be subject to Parliamentary scrutiny as a disallowable instrument. This is important because the principles will, in effect, have legislative force.
  • The GTR must not accept, or approve, any application that is inconsistent with a policy principle issued by the Ministerial Council.
The Ministerial Council may, on the advice of the Gene Technology Ethics Committee, issue a policy principle prohibiting certain applications of gene technology on ethical grounds. The policy principle will be clearly documented and subject to Parliamentary scrutiny. The GTR must not accept any application that is inconsistent with the policy principle issued by the Ministerial Council.

Another matter that people suggested Ministers could make policy principles on is GMO- free agricultural zones so as to protect Australia’s diverse farming practices.

Policy Guidelines
  • Policy guidelines will be issued by the Ministerial Council to assist the GTR in the performance of the GTR’s functions. These will be guidance notes to the GTR, and will not be prohibitive or akin to a direction, but will be advisory.
  • Unlike policy principles, the GTR is not compelled to act in accordance with policy guidelines. However, the GTR must take the guidelines into account in considering an application.
The Ministerial Council, may issue policy guidelines to the GTR about the matters to be taken into account when considering certain types of application for GMO licences. While the GTR must have regard to any such guidelines, they do not amount to a binding direction to the GTR and the GTR may act inconsistently with them if necessary.

Codes of Practice
  • The Ministerial Council may also issue codes of practice as guidance to applicants (researchers and industry) regarding how work with GMOs should be conducted.
  • Codes of practice must be developed in consultation with each of the committees established under the legislation, relevant Commonwealth and State agencies, industry groups and environmental, consumer and other groups.
  • The GTR may apply a requirement that a code of practice be complied with as a condition of licence. As the codes of practice may, therefore, have some legislative effect (as it will be expected that they be complied with where the GTR so determines) the codes of practice are also disallowable instruments and subject to Parliamentary scrutiny.
The Ministerial Council may issue a code of practice for the ethical conduct of gene technology research or for the transport of GMOs. Unlike policy principles (which would be mandatory in nature and could, for example, prohibit certain work form occurring) and unlike policy guidelines (which would be used by the GTR to assist his/her decision making), the codes of practice would be developed for industry and research organisations with the expectation that they be observed. The GTR may also apply a condition of licence requiring compliance with a code of practice issued by the Ministerial Council.

Technical and procedural guidelines
  • While not mentioned in this Part of the Bill, the Bill does provide the capacity for the GTR to issue technical or procedural guidelines (refer clause 27 - functions of the Regulator). For example, the GTR may issue technical or procedural guidelines about application requirements, the requirements for accreditation as an organisation or the certification of a facility.
  • The technical and procedural guidelines issued by the GTR will be similar to those currently issued by GMAC. These guidelines explain GMAC requirements in some detail, and assist people to make applications and comply with GMAC requirements.

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