The Commonwealth Gene Technology Act 2000 (the Act), which came into effect on 21 June 2001, was developed cooperatively by all Australian jurisdictions and involved extensive consultation with all major stakeholders. This included the general public, as well as research institutions, universities, hospitals, companies and organisations representing industry, consumer and environmental groups.
The Act, associated Gene Technology Regulations 2001, an inter-governmental agreement signed by all jurisdictions and corresponding State and Territory legislation comprise the nationally consistent regulatory system.
The Act establishes the Gene Technology Ministerial Council (GTMC) to oversight the implementation of the regulatory system, and a statutory office holder, the Gene Technology Regulator (the Regulator), who reports directly to the Australian Parliament. The Regulator administers the legislation with the support of the Office of the Gene Technology Regulator (OGTR) which is part of the Australian Government Department of Health and Ageing.
Three statutory committees provide advice to the GTMC and the Regulator on technical, ethical and community consultation issues relating to genetically modified organisms (GMOs) and GM products.
Interaction with other regulatory agencies
The Act is designed to operate in a cooperative legislative framework with other regulatory authorities that have complementary responsibilities and specialist expertise. As well as enhancing coordinated decision-making, this arrangement enables the timing of decisions to be aligned and avoids both duplication and gaps in coverage.
The organisations prescribed for consultation comprise the Australian New Zealand Food Safety Authority (FSANZ) that has responsibility for issuing standards for the safety, composition and labelling of food; the Agricultural Pesticides and Veterinary Medicines Authority (APVMA) that regulates the use of herbicides, insecticides and animal therapeutics; the Therapeutic Goods Administration (TGA) that authorises the use of human medicines and medical devices; the National Industrial Chemicals and Notification Assessment Scheme (NICNAS) which oversights the introduction of industrial chemicals; the National Health and Medical Research Council (NHMRC) that advises on gene therapy trials and regulates research with human embryos; and the Australian Quarantine Inspection Service (AQIS) that controls imports that pose a pest or disease risk into Australia.
The Regulator is required to liaise closely with other regulators to ensure the identification, evaluation and management of risks that may be associated with the intentional release of GMOs into the environment (see below). Consequential amendments made to the legislation of those authorities oblige them to consult the Regulator in their assessment of GM products and to inform the Regulator if approvals are issued. This enables the Regulator to fulfil a statutory obligation to maintain a public record of GMOs and GM product approvals.
The functions of the Regulator also include monitoring international practice in relation to the regulation of GMOs, and maintaining links with international organisations that deal with the regulation of gene technology and with agencies that regulate GMOs in other countries.
Nature and scope of assessments and approvals
The object of the Act is to protect the health and safety of people and to protect the environment, by identifying risks posed by or as a result of gene technology, and by managing those risks by regulating certain ‘dealings’ with GMOs.
Under the Act any dealings with genetically modified organisms are prohibited unless they are appropriately authorised. Dealings are very broadly defined to include the conduct of experiments with, manufacture, import, transport, supply or disposal of a GMO. The type of authorisation is determined by a range of factors including the level of knowledge and experience with the GMO and the extent of the containment conditions applied.
Where GMOs are intended to be released in to the environment, the regulatory system anticipates a staged process of development of GMOs that starts in certified contained facilities and proceeds through small-scale, stringently controlled field trials before larger-scale, reduced containment or commercial release can be contemplated. This enables the Regulator to require data to be collected about the GMO at each stage of this step-by-step process in order to reduce uncertainty around assumptions made in risk assessments, and to test the efficacy of containment measures.
The results of this research may result in changes to licence conditions to better manage risk and will inform future evaluations of the same or similar GMOs.
At the same time the developer is enabled to collect data on performance and scale-up requirements that can be used to make decisions as to whether further development is warranted. Such data would also be essential for obtaining approvals from product regulatory authorities to manufacture and sell GM products that are, or are derived from, GMOs.
CSIRO’s recent decision to discontinue a project to develop weevil-resistant field peas when allergic responses occurred in mice that were fed the GMOs is a practical example of this. The research was conducted in anticipation of applying for regulatory approvals from both FSANZ and the OGTR.
As the animal model used has not been validated to predict human immune or allergic responses to food, no conclusions can be drawn about whether actual harm to humans would occur if the GM peas were consumed by people. CSIRO’s decision reflected a cautious approach and the test data were never actually submitted to regulatory authorities.
The Act stipulates a comprehensive process that the Regulator must follow in assessing applications for licences to release GMOs into the environment – the most highly regulated category of dealings. This includes a requirement to consult extensively with a wide range of expert groups and authorities, including the prescribed agencies mentioned earlier, the Gene Technology Technical Advisory Committee and state and territory governments, as well as the public.
To date the Regulator has issued seven licences for the commercial-scale release of GMOs, comprising three insect-resistant and/or herbicide-tolerant cottons, two herbicide-tolerant canolas (one of which also contains a hybrid breeding system), a blue carnation and a cholera vaccine. Thirty-seven limited and controlled release licences have also been issued. These include trials of a range of other crops and introduced traits, such as delayed-ripening papaya and drought-tolerant wheat. Extensive information on current and previous assessments is available on the OGTR website (www.ogtr.gov.au).
The Act also empowers the Regulator to accredit organisations to conduct work with GMOs and to certify physical containment facilities, as well as conferring substantial monitoring and compliance powers.
Role of state and territory governments
In drafting the gene technology legislation, Australian Governments confined the Regulator to the consideration of risks to human health safety and the environment. This was in part because of concerns raised during consultation on its development that a requirement to consider economic issues could compromise the Act’s focus upon protection of people and the environment.
This decision also recognises that states and territories are primarily responsible for economic development issues within their respective jurisdictions, and the Act anticipated they might act to limit commercial releases of GM crops by providing for the Gene Technology Ministerial Council to issues a policy principle to recognise areas designated under state/territory law to “preserve the identity of GM or non-GM crops for marketing purposes”.
All states and territories except Queensland and the Northern Territory have introduced legislation that enables the imposition of controls on the commercial introduction of GM crops that have been authorised for release by the Regulator on human health and environmental safety grounds. The cultivation of the two GM canolas mentioned above has been prevented until market impacts and segregation practices are better understood. Field trials under contained conditions may be permitted and the cultivation of other GM crops (for example, GM cotton in NSW) can still be allowed.
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