Jan McLucas (Queensland, Australian Labor Party, Shadow Minister for Ageing, Disabilities and Carers) Share this | Link to this | Hansard source

The purpose of the Gene Technology Amendment Bill 2007, which we are dealing with today, is to amend the Gene Technology Act 2000 for a range of purposes. These include the introduction of emergency powers to give the minister the ability to expedite the approval of a dealing with a genetically modified organism in an emergency. It also includes the creation of the Gene Technology Ethics and Community Consultation Committee and amendments to the process for assessing applications for GMO licences.

Labor will be supporting the passage of the bill through the parliament. We understand there are strong views in the community both for and against gene technology; however, the debate on this bill is not a debate on the merits or otherwise of gene technology. Rather, the amendments to the act which are proposed in this bill are by and large designed to improve the operation of the act and will not change its underlying policy intent or the overall legislative framework. Further, the amendments proposed by the bill also represent the culmination of a long public consultation process and an independent statutory review process. They are also supported by the intergovernmental Gene Technology Ministerial Council. For all of these reasons, Labor will be supporting the bill.

The Gene Technology Act is the Commonwealth legislation which regulates genetically modified organisms in Australia. The object of the act is to protect the health and safety of people and the environment by identifying risks posed by, or as a result of, gene technology, and by managing those risks through regulating certain dealings with genetically modified organisms.  Under the Gene Technology Agreement 2001, all states and territories have committed to maintaining corresponding legislation. In 2005-06, an independent review of the act and the Gene Technology Agreement was undertaken, headed by Susan Timbs. The review concluded that the act and the national regulatory scheme had worked well in the five years following their introduction. The review recommended a number of changes aimed at improving the operation of the regulatory scheme. This bill implements the recommendations from the review that require changes to Commonwealth legislation. The amendments contained in this bill reflect the ministerial council’s response to the statutory review and have been agreed by the states and territories.

I now want to turn to the specific amendments proposed by the bill. The proposed new emergency powers are the most contentious aspect of the bill. These new powers will give the minister power to expedite an approval of a dealing with a genetically modified organism in an emergency, in recognition of the fact that situations may arise in which approval of a dealing with a GMO may be required in a limited time. The issue of emergency powers was considered at length in the Senate committee’s inquiry and report on the bill. Some witnesses before the inquiry—including Gene Ethics and Greenpeace—expressed concern about the proposed new powers and whether they are necessary. While Labor is somewhat cautious about the proposed emergency powers, on balance we agree with the view of the majority of the Senate committee that there will be sufficient checks and balances in place to ensure the emergency powers are not used injudiciously.

The safeguards on the emergency powers that will be in place include: the minister will be required to have a recommendation from the Chief Medical Officer and/or the Chief Veterinarian before invoking the powers, and the minister will be required to consult with the states and territories before invoking the powers. We also note that guidelines for the administration of the emergency dealing provisions have been developed though a process of consultation with the states and territories. On the strength of these provisions, Labor is satisfied that the minister will not be able to act unilaterally and that the powers will be used with sufficient circumspection. However, Labor’s strong view is that the powers should only be used as an absolute last resort.

The bill will also establish a Gene Technology Ethics and Community Consultative Committee. This new committee will combine the existing Gene Technology Ethics Committee and the Gene Technology Community Consultative Committee into one body. The new committee will provide advice to the Gene Technology Regulator and the Gene Technology Ministerial Council on ethics and community consultations. The combined committee will also provide advice on risk communication and community consultation around intentional release licence applications. During the Senate inquiry, most stakeholders commented favourably on the proposed amalgamation of the ethics committee and the consultative committee into the one body.

The bill also proposes amendments to the process for assessing applications for licences for GMOs. There are two sets of amendments in this section of the bill. The first set of amendments will alter the order of events during the initial licence consultation process so that the regulator would no longer be required to consider whether an application poses a significant risk to the health and safety of people or the environment before developing a risk assessment and a risk management plan. These amendments are designed to improve the process by which licences are initially considered and give the regulator more time to consider whether dealings pose a significant risk. The second set of amendments would introduce a new category of licence for GMOs to distinguish between licences for a limited and controlled release and licences for intentional release. The object of these amendments is to increase the efficiency of the regulatory system by streamlining the application process for licences involving a limited and controlled release of a GMO. The issue of the new limited and controlled release licences was the topic of some discussion at the Senate committee’s hearing into the bill. Some stakeholders expressed concerns about the proposed new assessment process as it relates to limited and controlled release. However, the Senate committee supported the passing of the relevant provisions without amendment.

Other amendments to the act proposed by the bill will make various changes to the gene technology regulatory scheme. These changes include streamlining the process for the initial consideration of licences and the reduction of the regulatory burden for low-risk dealings, clarification of the circumstances in which licence variations can be made, clarification of the circumstances under which the regulator can direct a person to comply with the act, the provision of power to the regulator to issue a licence to protect persons inadvertently dealing with a GMO so as to enable appropriate disposal of such organisms and the making of technical amendments as proposed by the Office of the Gene Technology Regulator.

In conclusion, as I said at the outset, Labor will be supporting the bill. While the proposed emergency powers are somewhat contentious, we are satisfied that there will be sufficiently robust safeguards in place to ensure that these powers will not be used unwisely. The remaining provisions in the bill are relatively uncontroversial and Labor is happy to support their passage through the parliament.

Annette Hurley (SA, Australian Labor Party) Share this | Link to this | Hansard source

I rise to support the Gene Technology Amendment Bill 2007. The application of gene technology is a contentious issue, and in Australia scientists, regulators and farmers have trod very warily in implementing this new form of technology. That is a very justified caution on the part of people in Australia. Some countries—such as the United States and countries in Europe—have gone more quickly. They have implemented new crops with altered genes. There is debate about whether that has been successful or not. A quick perusal of the internet will find examples of people who believe that there have been disasters as a result of the planting of altered gene crops. But these are refuted by others, so it is in fact difficult for the layman to get any clear indication of where this is heading and how safe alteration of genes in plants and animals is. I like to compare it to the biological controls which have been used for some time. I suppose a lot of people concentrate on some spectacular failures in biological control in Australia. One that continues to have its effects is the cane toad, which was originally introduced to control the cane beetle in Queensland. It was discovered that the cane toads ate not only the cane beetles but also a large number of other things and have spread all through Queensland in almost plague proportions and are now spreading in the Northern Territory and apparently in Western Australia as well and causing difficultly for native wildlife. There are other examples both in Australia and round the world of where scientists in a supposedly controlled environment have introduced an organism to control other organisms and it has gone wrong.

However, by and large that has been very successful in Australia. There are a number of examples that have been and are still being used very successfully in Australia, where biological organisms have been introduced to control plant or animal pests. One example is the use of nematodes, which are used to control slugs, for example, in agriculture. A more well-known example is cactus, which has been more or less wiped out in most parts of Australia. Biological controls over the years have proved to be very successful economically. Even where they have been less successful, they have proven to have a reasonable benefit-to-cost ratio in crop production. The new advances posed by gene technology are very much along similar lines.

We are fortunate in Australia to have the CSIRO and other organisations, such as SARDI—the South Australian Research and Development Institute—which have good expertise in biological control and crop research and other agricultural research. They have a long history of proven, concrete, reliable research and have proved to also have good regulatory controls. I think that gives us great comfort in allowing this slight loosening of the licensing requirement for gene technology and allowing gene technology to be used in emergency situations. We have that background of expertise in leading-edge research and development in our primary industries—which is something that is perhaps not so widely recognised—and in health, where Australian research and technology is very well recognised.

We have been quite right to proceed warily in this area. In general we should support this bill and the amendments to the current Gene Technology Act. Certainly we should not ever let our guard slip, and I suppose that is where the anxiety comes in, in terms of the emergency powers. One situation cited is where emergency powers may be used if there is an avian flu epidemic spreading quickly throughout Australia, causing loss of life or debilitating illness, and where governments and regulators may be panicked into allowing a genetically modified organism into our system that has far more adverse consequences than the original organism. That is a great threat that we should be very aware of and have in the forefront of our minds. Our experience with micro-organisms and the manipulation of micro-organisms is probably not as great as it has been with plant and human health and other large animal health, so I think we need to tread very cautiously in this instance.

There is still a lot we do not know about the behaviour of bacteria and viruses in the body and the way that they might cross over between species. There is still some debate about whether or not or how easily micro-organisms can cross between species and produce disease or various other effects. I think we should certainly err on the side of caution when considering human intervention in these matters. We should always have in the forefront of our minds those relatively few but still potent examples of where biological control has gone wrong in our environment.

That being said, I think a great deal of good work has been done in gene modification technology, both in primary industry and microbiology in Australia and the rest of the world. This is a very exciting new technology that may reap great benefits in our production of food sources, for example. We are all worried about climate change, and this technology may lead to the production of drought resistant crops, crops that are resistant to humidity in some areas and crops that are resistant to extreme cold or extreme heat. Unless there is an abrupt and sudden reversal of what seems to be a change in our world climate, it is difficult to see us juggling the requirements of an expanding population and expanding the need for resources without some form of gene technology to assist us. I know that this is anathema to some people who do not like to interfere to any extent in our ecology, but it is difficult to see how we might advance into the future without some use of that technology to relieve widespread problems in adapting to the change in our world climate and conditions, both in human health terms and in animal terms.

Rachel Siewert (WA, Australian Greens) Share this | Link to this | Hansard source

The Australian Greens do not support the introduction of these specific emergency dealing provisions. We have serious concerns about their implications. We may be putting in place a cure that is far worse than the disease or the original problem. The Greens, as many people will know, have some very strong concerns with genetic engineering and its implications for our environment and human health. However, I am not going to dwell extensively on those specific concerns at this time. I am going to specifically deal with some of our concerns with these amendments. As they stand, these provisions would essentially enable the fast-tracking of potentially untested genetically modified organisms—alternatively called genetically engineered organisms—into the environment in an attempt to solve an emergency potentially unrelated to genetically modified organisms.

The proposal is to dispense with the full assessment process of the potential impact of the release of a GMO—not merely to expedite it or to speed up the process but to in fact dispense with it in some circumstances. We are deeply concerned that this means that an unknown and potentially harmful organism may be released without any fail-safe provisions or any understanding of how it may interact with other organisms or our environment, and that this could then be beyond recall. We could possibly do this—forever—without understanding the possible consequences. Genetically modified organisms released into our environment without proper assessment and testing may potentially have far-reaching, dangerous and disastrous consequences.

We need to take these potential dangers into account in a precautionary fashion when weighing up the risks and benefits of an emergency response to an outbreak of disease or a pandemic to be sure that the treatment does not end up being a much bigger problem than the one we were trying to solve in the first place. We already have more than enough examples in Australia of hasty interventions where the cure has in fact proved to be a greater problem than the disease. We need go no further than the already mentioned cane toad to establish this fact and to see that this has had huge environmental and economic impacts in Australia.

To summarise the Greens’ concerns, which I will go into in more detail in a moment: we are dealing with genetically engineered responses to a non-GE emergency, and we believe this goes beyond the scope of the original act. The decisions about emergency responses to disease outbreaks and pandemics need to be made by the relevant expert authorities. The release of GMOs, particularly untried and unassessed ones, should be the last resort and not the first one. We believe it should be restricted to medical emergencies only. There need to be very clear protocols within the act to define what constitutes a threat and to spell out what the triggers should be. We need a clear risk assessment process to carefully weigh up the potential costs and benefits of different emergency processes, and we need an assessment in place before the release of any GMOs.

We are concerned that this bill seeks to put emergency provisions in place within the Gene Technology Act 2000 that deal with non-GM emergencies. The changes proposed in the bill go well beyond the scope of the object of the act. The act states:

The object of this 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 through regulating certain dealings with GMOs.

It is very clear that the legislative intent of the Gene Technology Act was to identify and manage risks that are posed by gene technology. To the extent that the emergency declaration provisions relate to risks that arise as a result of threats not associated with genetically engineered organisms, they appear to lie outside the intended ambit of the act. An assessment of the level of threat posed lies outside the ambit of the expertise and the experience of the Office of the Gene Technology Regulator.

In the face of an emergency, we need to have the most effective response possible. We know that and acknowledge it. This means that we need to have the most appropriate authority making the decisions and managing the response, which requires relevant knowledge, experience and expertise. We want the most effective and efficient response to get the best outcome for the least amount of risk. This means considering all possible responses, including GE and non-GE ones, to pick the best one. We do not want to have a system that assumes a GE response is necessarily the best one, or where the expertise on tap only relates to one subset of possible responses. Surely, if there were a medical emergency, the Therapeutic Goods Administration emergency powers would be the first invoked, and we would expect the TGA to have access to the necessary knowledge, skills and expertise to evaluate the threat to human health.

The relevant experts would look for solutions which might or might not include GMOs. We would not necessarily expect this expertise to reside within the Office of the Gene Technology Regulator, and developing or retaining such expertise would be an expensive exercise. The same applies for animal diseases. If we are to have emergency provisions to allow rapid response to an imminent threat—and here I will define, as I have looked it up, what ‘imminent’ means: ‘instant, overwhelming and leaving no choice of means and no moment of deliberation’—then I have very strong concerns, if those are the criteria we are going to apply to releasing untested, untried, unassessed GMOs into the environment. We should be making sure that the most appropriate body assesses the threat and coordinates the response.

In the case of a human vaccine responding to a serious outbreak of a major disease this might, for instance, result in the TGA declaring a medical emergency and then requesting the GTR to make an emergency assessment of a genetically engineered vaccine. To give the health minister and the TGR the primary power to respond to an emergency with GMOs would shut down full consideration of all the options, which might include safer or more conservative solutions. In the case of a genetically engineered human vaccine in response to the threat of an outbreak of a particular disease—and this is one of the reasons put forward for the need for these provisions; for example, to deal with bird flu—it would be necessary to vaccinate a much larger number of people who have the potential to contract the disease than those who might actually be exposed and contract the disease in order for the epidemiological containment response to be effective. In other words, you would have to immunise a larger part of the population.

Where the vaccine contains a genetically engineered organism which is untested and may have adverse effects on some or all recipients, this has the potential to impact on a much larger population than would otherwise be affected. That is why there are currently such stringent assessment criteria related to vaccines and why we should not be considering bypassing these stringent rules without a very stringent risk assessment process. The existing provisions for testing vaccines and assessing genetically engineered and genetically modified organisms prior to release into our environment or into our community are there for a very good reason. They reflect widespread community concerns about genetic engineering and embody community standards, and they acknowledge that there are significant risks that have to be assessed and managed to protect the public. I am not convinced that the proposed emergency provisions are sufficient to do that.

I would like to look at what I have termed the triggers and levels of threat that apply to this legislation. The Greens are very concerned that the triggers and the level of threat necessary for declaring emergencies are not clearly defined. The definition of ‘imminent’ can include instant, overwhelming and leaving no choice of means and no moment for deliberation. The Department of Health and Ageing said in the committee hearing that one of the triggers for such a declaration might be an economic threat, not just an emergency around human health. An economic threat is not defined. Who defines what an economic threat is, the level of it or the severity of it? This may be considered a trigger for these provisions. The Greens do not accept that an economic threat would be sufficient justification to release a genetically engineered organism that has not been properly tested or assessed and which may pose an unknown and potentially unacceptable risk to human health or the environment. We do not accept that argument. The notion that these powers could be invoked for purely economic reasons is unacceptable, particularly when the release of an experimental organism may in itself pose an unknown economic and environmental health risk.

We also question how the situation might arise where there was a vaccine for a serious livestock disease that posed a major economic threat to Australian livestock that was already in use or looked at overseas and yet Australian livestock authorities were not sufficiently forewarned of this threat to get the assessment process underway before there was a major outbreak or the need to invoke emergency powers. The Greens believe that, if this amendment dealing specifically with emergency dealing provisions proceeds, it should be strictly limited to medical emergencies only. This way you could deal with life-threatening issues for human health but not so-called economic threats.

The bill does not specify the level of threat required to trigger the emergency dealing provisions. We believe that what counts as an imminent threat needs to be clearly defined in the act. As I have already said, we have concerns about the definition of the word ‘imminent’. The worst threat is not explicitly defined, yet the bill proposes that the minister merely has to satisfy that a threat is imminent without requirements or procedures to prove that a significant threat really exists. As it stands, the concept of threat within the act relates to pests and diseases, but there is no requirement that the threat be of a particular imminence, severity or scale. This is supposedly in the ministerial guidelines that neither the public nor the Senate has seen. I tried to get them. They went to the ministerial council on Friday and I could not get them. So we are dealing with a bill now for which we have not seen the ministerial guidelines that define threats or triggers for this act that could potentially have disastrous consequences for the Australian community and environment. The act should be clear that any real threat of a specified scale, scope and severity to justify the use of the emergency powers is reviewed and confirmed by all jurisdictions and that the circumstances are so exceptional as to justify an emergency response to avert a widespread impact on human health. Given that the minister is being required to make a decision in response to a particular threat, which in itself also inherently contains an element of risk, it seems negligent to be introducing a system in which the scale of threat, the likelihood of adverse outcomes and the relative costs of acting or failing to act are not considered in light of the potential risks posed by the introduction of an unassessed, untried, potentially experimental GMO. We believe that this should be required in the legislation.

We understand from evidence that was given to the committee that the ministerial council has just considered guidelines relating to emergency provisions. This clearly suggests that the ministerial council still has concerns about the provisions which these guidelines are intended to address. As I said, we have not seen them, the public has not seen them and stakeholders have not seen them. Given the uncertainty that remains within the act about what constitutes a significant imminent threat and how possible response strategies might be assessed, it seems that the completion and approval of these guidelines would be a prudent and necessary first step before the introduction of this bill. The Greens believe that the ministerial guidelines should be a legislative instrument that is incorporated into this bill.

I would like to briefly touch on some of the horror stories that abound with genetic engineering to highlight the reasons for our deep concerns. There was the Klebsiella planticola case in which a GM microbe for producing ethanol on farms was approved by the USDA, but when independently tested just prior to release was found to continue producing ethanol in soil, where it would destroy susceptible plants—in fact, most of them. The release of this organism was stopped only at the eleventh hour. In Brazil, GE soya beans incorporating a nut gene produced severe allergic reactions in some people and had to be withdrawn. These were genetically modified organisms that had been tested and released and still had problems. They were not untested and unassessed GMOs such as are potentially going to be released into the environment. In the US the release of herbicide tolerant GE crops has led to an escalation of weed problems and there are a high number of people manifesting allergies to GE corn and soya products. Recent reports of the widespread death of bees and the collapse of bee colonies across Europe and the US are a cause of major concern not only for the honey industry but for food crops and ecological systems that are dependent on them as pollinators. We do not know at the moment what is causing this—it remains a mystery—but research is pointing to the total collapse of the immune system of the bees from unknown causes. There are a number of different and competing explanations about a multitude of possible causes, including agricultural chemicals and the uptake of GE crops. Those are some quick international examples.

In Australia just recently, and as I articulated in this place not long ago, there was the experience of research done on mice at the ANU. The ANU conducted research into feeding genetically modified peas to mice. The CSIRO modified the peas to contain a bean gene which was intended to produce resistance to pea weevils. This resulted in a substantial change to the protein produced by the peas. The mice developed a hypersensitive skin response and experienced airway inflammation and mild lung damage. This could have had serious consequences if it had been released.

And there is the example that we heard in the Senate inquiry from Jeremy Tager. He said:

I remember that my father was working for the National Institute of Health in the 1950s when they rushed through a polio vaccine with the notion that this was an emergency that needed dealing with. They ended up killing more people than they saved with that particular vaccine.

I go through these examples to highlight the dangers that we are facing if we circumvent what I think are very important provisions and safeguards in our legislation. That is why we are very concerned that these particular provisions are being brought in to cover a much broader range of circumstances than we believe is appropriate and that they do not properly outline the levels of threat and risk in which these provisions would be invoked.

When we asked about this in the committee we were told, ‘Of course it’s only going to be used in real emergency situations.’ Well, we need to ensure that that is in fact what is going to occur. We cannot rely on people in the heat of the moment making what may be inappropriate decisions when they think that there is no alternative and in a moment when supposedly there is no time for consideration or deliberation. We do not believe this is appropriate when we are dealing with such potentially significant consequences.

We believe that attempts to use the Gene Technology Act 2000 to specify a means of fast-tracking or bypassing the assessment of genetically engineered organisms to allow them to be released into the environment or our bodies in response to a non-GE related emergency go well beyond the objects of this act. While we believe there is a need for legislative provisions for dealing with emergency situations such as pandemics or the outbreak of serious disease, we do not believe that these amendments are the appropriate way to do that.

The Greens will be moving amendments in the committee stage to oppose these provisions because we believe they need to go back to the drawing board. If they are not supported we will move some amendments to define what we mean by threat and the triggers for the use of these emergency provisions.

Brett Mason (Queensland, Liberal Party, Parliamentary Secretary to the Minister for Health and Ageing) Share this | Link to this | Hansard source

I thank Senator McLucas, Senator Hurley and Senator Siewert for their contributions. The Gene Technology Amendment Bill 2007 strengthens the Australian government’s component of the gene technology regulatory scheme. This scheme protects the health and safety of people and the environment from any risks that may be posed by genetically modified organisms.

These amendments are the response to the statutory review of the Gene Technology Act 2000 and the Gene Technology Agreement 2001 which was conducted in 2005-06. These amendments will refine the legislation and ensure that regulatory burden is commensurate to risk, introduce provisions to deal with unexpected situations and ensure the smooth operation of the scheme.

I note, and I think all senators agree with this, that we must always be judicious in our release of any genetically modified organisms into the community. I agree with all senators on that. Perhaps like Senator Hurley, however, I remain optimistic—perhaps more optimistic than Senator Siewert—as to the utility of GMOs. But only time will tell. Perhaps in the committee stage we will have more opportunity to flesh out that debate and look at future opportunities.

Senator Siewert spoke passionately about the emergency dealing determinations that are an integral part of the bill and that reflect, of course, the review that was completed in 2005-06. We will discuss this in greater detail in the committee stage, but can I just say—through you, Mr Acting Deputy President—that these are not unilateral powers that can be used by a minister. They are highly circumscribed. I will not go through all the provisions now, but the minister must receive advice from various officers, including the Gene Technology Regulator. He or she must be satisfied that there is an actual or imminent threat, and so forth. This is not a case of a unilateral decision by a minister; it is highly circumscribed.

I should also add that all these conditions and provisions were agreed to by states and territories. We will obviously get to that in the committee stage, but I just wanted to try to argue the case anyway, Senator Siewert, that we are not talking here about the unilateral decision of a minister. It is highly circumscribed. Also, you spoke about the definitions. Again, we can get into that in the committee stage, but the strong scientific assessment framework of the act will be maintained. That is why, in relation to the issue you raised about economic harm, that is not what the bill says and that is not what is contemplated. But, again, we will get to that later.

These amendments mean that the regulator’s resources may be more efficiently utilised in the evaluation of an application for the intentional release of genetically modified organisms and that the regulatory regime will be more able to respond swiftly to emergency scenarios where the use of a genetically modified organisms may be particularly advantageous. Furthermore, these refinements represent the collective input from all the states and the territories and will ensure that Australia has a world-class regulatory system that protects the health and safety of people and the environment as well as promoting research in this growing industry.

The amendments to the act serve to strengthen this link in the armour of protection afforded to the health of the Australian people and the environment by the Australian government. The Office of the Gene Technology Regulator, along with other Australian government regulatory schemes, provides a shield that protects the health of the Australian people and their environment.

Senator Siewert quite justifiably mentioned the guidelines for emergency response under the Gene Technology Act 2000 and the Gene Technology Agreement. She quite correctly referred to those. They were agreed to by the ministerial council last Friday and I table them. I commend the bill to the Senate.

Question agreed to.

Bill read a second time.