Stephen Jones (Throsby, Australian Labor Party, Shadow Parliamentary Secretary for Regional Development and Infrastructure) Share this | Hansard source

The Gene Technology Amendment Bill 2015 amends the Gene Technology Act. It is not often that this piece of legislation, or indeed this subject matter, gets debated in this House, so I may take the opportunity to go through the regulatory regime and the importance of having a firm but enlightened regulatory system in place in this area of public policy. The Gene Technology Act 2000 is the Commonwealth component of the nationally consistent regulatory scheme for gene technology in Australia. The object of the act is to protect 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 through regulating certain dealings in GMOs. The act establishes a regulatory framework to provide an efficient and effective system for the application of gene technologies that operate in conjunction with other Commonwealth and state regulatory schemes relevant to GMOs and genetically modified products.

In 2000, a regulatory framework was established, with the Gene Technology Regulator responsible for making the majority of decisions relating to gene technology and GMOs. The regulator is an independent statutory office holder and is not subject to direction by anyone in relation to the performance of his or her functions—in particular, whether or not to grant a GMO licence with or without conditions. The regulator is responsible for the decisions on particular applications, is subject to guidance at a general level from the ministerial council and is ultimately responsible to this parliament.

In 2011, the Department of Health, formerly the Department of Health and Ageing, commissioned a review of the act on behalf of the Legislative and Governance Forum on Gene Technology, formerly the Gene Technology Ministerial Council. The review investigated three areas: firstly, emerging trends and international developments in biotechnology and its regulation; secondly, the efficiency and effectiveness of the operation of the act consistently across the national scheme for gene technology regulation in Australia; and thirdly, the interface between this act and other acts and schemes for regulation of related entities throughout the Commonwealth.

The review found that, overall, the act and the regulator were operating very well. The Gene Technology Regulator was found to be performing its functions in a very efficient manner, but there were aspects of the act's implementation at state and territory level that required attention. The review also noted that current consultation processes in relation to applications under the act were working well. However, it did make 16 recommendations. Of those, 14 were accepted by the ministerial council. This bill seeks to amend the act to implement five of those 16 recommendations. Those five were all agreed to by the ministerial council. In our view, they are minor and technical amendments that do nothing but enhance the overall operation of the regulatory scheme, but I will go to them in a little bit of a detail.

The amendments improve the act's operation without changing the underlying policy intent, the overall legislative framework or the legislative scheme. The bill discontinues quarterly reporting to the minister. That does not mean that reporting to the minister is not required. Importantly, those things that were once subjected to quarterly report are now incorporated into an annual report. It clarifies which dealings may be authorised by inadvertent dealings licences, and it updates advertising requirements for public consultations. It also removes the duplicate information about GM products authorised by other agencies from the record of GMO and GM products. This will have the effect of no longer tracking the GMO products approved by the Gene Technology Regulator. In essence, what this section of the bill does is remove the duplication. There will still be a publicly available register of these items, but they will be found within the register of the respective regulatory agencies—for example, the TGA, APVMA, the Food Standards Australia New Zealand registry and the NICNAS registry.

The bill changes licence variation requirements to give greater flexibility to licence holders but not at the risk of public health and safety. It updates considerations required before dealings may be scheduled as notifiable low risk dealings. It requires that emergency dealings determinations be entered on the GMO record as soon as practicable, but it removes the requirement that information on GM products be entered as soon as practicable. It also clarifies some ambiguous wording within the act.

I will say a little bit about gene technology, because this is an area of intense public interest. I know that the member for Moreton, who will be speaking on this debate, will have something to say about these issues. Put simply, gene technology refers to a number of ingenious methods whereby genetic material, DNA, in the cells of target organisms is altered in very specific ways. Gene technology works because there is a remarkable similarity between the central biochemical systems of plants, animals, bacteria and fungi. The potential benefits from the application of gene technology include: more efficient use of agricultural and veterinary chemicals, savings in energy inputs to farm production, and the recovery of degraded land or being able to grow specific crops on land that would previously have been not viable. It also enables research into causes of diseases and improved biopharmaceuticals and bioremediation.

However, the very characteristics of gene technology which produce many of the benefits also cause concerns in the community. These concerns relate to potential unintended effects on the health of people or the environment. Some of the risks identified when the 2000 bill was originally introduced into the parliament go to this point. If you read the regulatory impact statement to the Gene Technology Bill 2000, it talks about the risks of allergic reactions to genetically modified foods—the concern that these genetically modified foods have a higher risk of allergic reactions. It talks about the unknown long-term consequences that may not be able to be reversed or fixed once GMO is widely used. And it talks about crops, for example, which may become so strong as to constitute a weed or pest within the Australian environment. Of course, there are also broader concerns in this area about using gene technology, including some of the ethical, social and moral concerns about the impacts of human beings effectively playing God.

Legal responsibility for gene technology regulation is vested in many regulatory bodies, depending on the intended use of the relevant genetic technology. For example, foods are regulated under state and territory food acts and therapeutic goods are regulated under the Therapeutic Goods Administration. And I do pause to say that this is a very exciting area of new technology in fighting diseases that were once certain death sentences. There is an enormous amount of very good research going into this area, particularly in relation to biologicals. Human gene therapy is also regulated by the TGA. Agricultural and veterinary chemicals are regulated by relevant authorities. There is a national scheme administered by the National Registration Authority. Industrial chemicals are regulated by NICNAS. Imports and exports of GM products and GMOs are regulated under the Quarantine Act and the Imported Food Control Act, amongst other pieces of legislation. As you can see from this, there is a complex regulatory scheme. But at the centre of it lies the Office of the Gene Technology Regulator.

Although the bill, on its face, seems non-controversial, given the subject matter and the keen community interest on this, when first appraised of it when it appeared before the parliament on the Notice Paper, we sought advice from a range of experts and stakeholders and asked that the Senate committee conduct a brief inquiry into it. That Senate committee has now reported. I am pleased to say that they received five submissions, including from CSIRO, the Office of the Gene Technology Regulator, the Australian Academy of Science, CropLife Australia and Food Standards Australia New Zealand. All five submitters to the inquiry supported the bill. There was no contra argument put to it. Notably, the Australian Academy of Science characterised the amendments as 'conservative and justified'. The CSIRO declared a strong support for the clear legislation of gene technology regulation. The bill enjoys the support of all Labor members on this side of the House. We will be supporting it.

I commend the legislation to the House. We commend all of those who have done the important work over many years to bring the matter before the House.

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