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A GE Cure Worse than the Disease

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 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 passing 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 of 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 that 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.

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