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Tuesday, 29 August 2000
Page: 19548

FRAN BAILEY (5:49 PM) —There have been three revolutionary processes that have changed forever the way in which society operates. They are the industrial revolution, the information technology revolution and the latest, the biotechnology revolution. The legislation we are debating here today, the Gene Technology Bill 2000, is a product of that third revolution. And let us make no mistake about it: the application of gene technology is revolutionary because it has the capacity to change some characteristics of many of the crops we grow—to increase their rate of production and to provide plants with the ability to grow in areas of high salinity where previously it was not possible for them to grow, to give just a couple of examples. As well as agricultural uses of gene technology, there are many applications like research in biology and medicine, production of therapeutic products like insulin for diabetics, and industrial uses like the production of enzymes for use in paper pulp production.

The process and application of gene technology has sparked passionate debate between those who support it and identify the benefits to the national economy, agricultural production, health and the environment, and those opposed to it, who proclaim the risks to people's health, the environment and agricultural production. As Chairman of the Standing Committee for Primary Industries and Regional Services—with your very able support, I might add, Mr Deputy Speaker Adams—I recently tabled a report that examined the role of biotechnology in agriculture, the risks and benefits, the role of traditional crops, research, development and commercialisation, and the type of regulation needed. The title of the report, Work in progress: proceed with caution, indicates the view that, as gene technology continues to be developed, great care needs to be taken. The report—with bipartisan support—which was released before this legislation was introduced, emphasised the urgent need for a rigorous, transparent and independent regulatory process to be implemented. This legislation meets those requirements.

Before examining the legislation in detail, however, I want to place on record exactly what is meant by gene technology, because there is not just a lack of factual information in the community but a great deal of misinformation. There are many who will attest that there is virtually nothing that can accurately be described as `natural' any more, after thousands of years of plant and animal breeding programs. As an example of that, a farmer recently reminded me that the first cobs of corn that were grown were about as long and as thick as my index finger while today his organic corn is very large and plump. The best definition I have come across about exactly what gene technology is is the example given in the committee report I referred to earlier. That was provided by the Australian Academy of Science, who said:

All living things are made up of cells. All cells contain genes, which determine the physical characteristics of an organism. The building blocks of genes are composed of DNA. While DNA is the same across all species, the variety of ways it can be put together creates the difference between species and individual organisms. On average, plants contain around 22,000 genes, and animals can have up to 50,000.

Gene technology includes a range of techniques that can control, modify or delete particular characteristics of an organism, and transfer desired traits from one species to another. These processes give rise to plants, animals and other organisms that are referred to as genetically modified The term `transgenic' describes plants or animals which have a new gene inserted into them.

Not every gene in an organism is active, and only the genes which are expressed are responsible for the characteristics of an organism. Much of the research undertaken in gene technology concentrates on activating or suppressing the expression of genes known to cause particular traits.

Desired traits can be transferred to different species through a number of methods.

The main uses of gene technology lead to the same output as conventional breeding programs, but with greater speed and precision; for example:

genetic markers easily and rapidly identify the presence of a particular gene, and helps with the selection of lines with desired characteristics; and

gene transfers from near relative species can be done faster and more easily through this technology than by conventional means.

I have already outlined the range of applications of gene technology. Currently, universities and other public research institutes like the CSIRO use gene technology for research and biotechnology. Pharmaceutical and agricultural companies use gene technology to develop commercial products. However, the very characteristics of gene technology currently used in such research which produce the means to achieve benefits for both producers and consumers are also those that cause concern in the community. The National Consensus Conference, submissions to my committee's inquiry and community meetings in my electorate have identified a range of concerns varying from health concerns of consumers to impact on the environment and potential contamination of traditional crops because of insufficient buffer zones separating genetically modified crops from, for example, organic crops. As well as these scientific, health and environmental issues, others have expressed real concern about ethical, social and moral issues.

The reality is, however, that the technology is here. It is being developed and refined at a rapid pace all around the world, even though in various countries governments and industry are publicly saying that the pace of development needs to be slowed down and more notice must be taken of consumers' concerns. I believe that the emphasis on primary producers and science and industry rather than on consumers is at least partly responsible for the lack of easily understood factual information in the public domain. Without this information, people have been unable to make informed decisions and have had to rely on the latest newspaper headlines for their information. Naturally, people are concerned about any new and revolutionary technology, especially one that could be responsible for changing the food that they grow and eat or used in the development and manufacture of pharmaceuticals. It is therefore absolutely critical that the regulation put in place to control the testing and the application of this new technology in science, industry and agriculture be as rigorous and open as is possible. Underpinning the control that this legislation will achieve is the aim to protect the health and safety of people and to protect the environment from any risks associated with gene technology.

The range of GMOs that already exist and genetically modified products are currently regulated in a variety of ways. In the case of food—and that includes GM food—states and territories have the responsibility and food standards are regulated through ANZFA. The Therapeutic Goods Administration, TGA, administers all therapeutic goods including GM goods and human gene therapy. The National Registration Authority, NRA, administers all agricultural and veterinary chemicals including GM products. The National Industrial Chemicals Notification and Assessment Scheme, NICNAS, administers industrial chemicals, including any GM products. As well, AQIS administers the regulations of imports and exports, including any GM products. Up to this point in time, any proposal from whatever source, whether for research and development or to progress to the commercial release of a product, has had to be submitted to GMAC, the Genetic Manipulation Advisory Committee, a non-statutory expert committee who rely on their own expert members and may consult experts outside their committee. Each proposal is assessed on an individual basis and GMAC reports to the Commonwealth Department of Health and Aged Care.

While this system was only adequate at best when GMO research was confined to research facilities, it is no longer appropriate when research increasingly consists of actual field trials. GMAC's resources and authority are now inadequate for being responsible for such examples of field research. Nor do they have the resources to ensure that the public are kept informed. As well, there are gaps that are not covered by either state or Commonwealth legislation. These include the growing of GM agricultural crops, the growing or breeding of GM animals or fish, the use of GM micro-organisms designed to decompose toxic substances and the use of GM viruses and vaccines, as well as by-products of GMOs such as stockfeed produced from GM agricultural crops. The system currently in place lacks credibility in meeting the demands and concerns of the public because there is not an openness and transparency to risk assessments, nor are there sufficient mechanisms in place for enforcement.

The recent breaches of canola trial conditions at Mount Gambier highlight the problems of the current system and the need to implement a regulatory system that is independent, open and transparent and which has the authority of accountability and enforcement. The community is right to demand that these mechanisms be put in place as soon as possible to ensure the health and safety of people and the environment while at the same time enabling Australia as a net exporting nation to keep pace with the rest of the world. It is therefore imperative that this stringent Commonwealth legislation be enacted as soon as possible and that this legislation be complemented by similarly consistent legislation by the states and territories. It is proposed that an intergovernmental agreement on gene technology be negotiated between the Commonwealth and the states and territories to establish a nationally consistent scheme. It is in the interests of everyone that Australia has a national and uniform system of regulation responsible for the day-to-day administration, to ensure that we have the most stringent regulation that will achieve the highest levels of health and safety.

There are three main ways in which regulation could be achieved: firstly, as I have just said, through a system which could best be described as a cooperative, nationally consistent regulatory scheme; and, secondly, through discrete legislation in each jurisdiction, which would create a gene technology body in each state or territory. This model would inevitably lead to increased costs all round because of the duplication across the nation. It may also lead to some businesses shopping around for the best deal. The situation could arise where one company could gain approval for testing or commercial release of a GM product in one jurisdiction but not in others. There would not be any assurance to the community of decision making across the nation. I believe this would undermine the confidence of the community in the integrity of the whole regulatory process, and of course any increases in cost to business because of the differences from one jurisdiction to another would be passed on to the consumers and could affect our export competitiveness. Thirdly, we could simply rely on the Commonwealth's broad constitutional powers to enact legislation to regulate GMOs. However, problems with this model for the Commonwealth would be in interstate trade and research being conducted by institutes that did not have cooperative arrangements. There would inevitably be numerous gaps, similar to those existing today, which would then have to be fixed by the enactment of state legislation. Obviously, this would lead to a lack of confidence by consumers and the inevitable duplication.

I believe that the first option would achieve a national consistency to regulation and therefore provide the highest level of protection for the health and safety of consumers, as well as providing a more streamlined approach for research institutes and businesses seeking approval for dealing with GMOs, while minimising costs which are a direct benefit to those investing millions in research and, importantly, to consumers. Most importantly, however, I believe that option minimises the potential for discrepancy between jurisdictions and covers any gaps in legislation. It is my belief that that option provides the best model for ensuring the achievement of all the characteristics of the optimum regulatory process—independence, openness, transparency and accountability. Add to this a rigorous and comprehensive decision making process based on scientific assessment of risks along with consideration of broader issues of national interest and ethics and then I believe we can say that we have legislation in this area that is leading the world.

Another aspect of this legislation I want to examine is the role of the Gene Technology Regulator, who is independent and not subject to direction from anyone in relation to the risk analysis process of GMOs nor on the granting or conditions of a licence. The regulator has extensive power of enforcement, including the ability to cancel, suspend or vary a licence accreditation or certification, reporting breaches to parliament or, in extreme cases, criminal penalties. Part 5 of this legislation details the extensive process of licensing applications. As well as monitoring international practices in relation to the regulation of GMOs and maintaining links with international organisations, the regulator must provide information and advice to other regulatory agencies and to the public. It will be the regulator who decides whether information is commercial-in-confidence or can be released to the public.

In keeping with the philosophy of open and transparent regulation, this legislation provides for a centralised database of all GMOs and GM products—including conditions of licence—approved in Australia to be publicly accessible. This will mean that research institutes and companies will have to prove a commercial-in-confidence status rather than, as in the past, simply claiming that status. While this legislation allows for the regulator to table reports in this House and in the other place at any time under section 137, giving the regulator similar power as the Auditor-General, it was my committee's recommendation that the regulator report to the parliament at least quarterly for the first three years. I strongly support that recommendation.

Importantly, throughout the entire regulatory process there will be opportunity for community input. There is no doubt that the community has suffered from lack of factual information and it is vital that they receive it. For this reason, I state again on the public record, as stated in my committee's report, how important it is that Biotechnology Australia be made a statutory authority. If BA is to be a credible source of information, it must not only be seen to be independent but be independent. By being a statutory authority, it would be at arms-length from ministerial control while still accountable to parliament and subject to audit by the Auditor-General.

The final point I want to make is on the question of cost recovery. There is no doubt that such a tough system of regulation of GMOs and GM products will be expensive. I certainly do not believe that Australian taxpayers should foot the bill for the extensive costs that large and well established companies will incur under our Australian system of regulation, but I do have some concerns about the small Australian companies who have committed themselves to expensive research only to find they cannot afford to progress to licensing their research for commercial applications.

I give as an example a small family owned company, Valley Seeds Pty Ltd, from my own electorate. This is a company that has been breeding grasses for 25 years and for the last seven years has been supporting researchers at Melbourne University to eliminate the allergy effects of grass pollen. Professor Singh and Dr Bhalla from Melbourne University have successfully managed to `switch off' the allergy causing genes in rye-grass after isolating genes in the grass pollen that cause hay fever. As the commercial partner for the development of this technology, Valley Seeds, while hailing this development as a major breakthrough, sees the major benefit of this development for the public good, used on roadsides and public gardens. The cost, however, to this small family company of getting their genetically modified variety accredited and certified for commercial use could well be beyond their capacity and, sadly, members of the public would miss out. I am aware that KPMG are conducting a study into the proposed cost recovery options and I would urge them to take this sort of example that I have just given into account.

In conclusion, I want to say how pleasing I believe it is that so many speakers in this debate have been speaking about the need to implement such strong legislation and also have reinforced the need for a cautious approach.