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REGULATION & POLICY: The Australian Greens on the GMO Actemergency dealing provisions

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Inquiry into Gene Technology Amendment Bill 2007

                                  PART I
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TITLE:  Genetic Modification laws too risky
SOURCE: Wimmera Mail-Times, Australia
AUTHOR: Michael Reid
DATE:   24.05.2007

Genetic Modification laws too risky

NEW EMERGENCY powers that allow Australian authorities to fast-track  
the release of genetically modified organisms could pose unacceptable  
risks, say critics.

According to a bill passed by the Senate this month, the Health  
Minister could hypothetically order the rapid approval of a GM vaccine  
to fend off a bird-flu pandemic, or a GM bacterium to ,,eat" an oil  

But critics are concerned emergency powers in the Gene Technology  
Amendment Bill 2007 could lead to inadequately tested GM organisms  
being released.

Australian Greens senator Rachel Siewert says, ,,There's a very real  
danger that the cure could be worse than the disease. We do not want  
to create another cane toad."

The Department of Health disagrees, and says the Minister will only  
have the power to declare an emergency release of a GM organism if  
convinced there is an ,,actual or imminent threat" and if the action  
will be effective.

The Minister is required to consult states and territories, and  
officials such as the Gene Technology Regulator, Chief Medical  
Officer, Chief Veterinary Officer or the Chief Plant Protection  
Officer must also advise.

But Siewert says the bill does not contain enough detail on the  
circumstances that could justify fast-tracking a release, leaving it  
up to the Minister and a handful of advisers.

But the Health Department says the Bill is ,,very prescriptive" about  
how powers can be used. And the Minister can only order an emergency  
release if the Gene Technology Regulator says risks can be ,,managed  

Siewert says there won't be time for proper deliberation to determine  
whether the risks of releasing a GM organism outweigh the benefits.

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                                  PART II
------------------------------- GENET-news -------------------------------
TITLE:  A GE cure worse than the disease
SOURCE: Senator Rachel Siewert, The Australian Greens
AUTHOR: Senate Speech of Rachel Siewert
DATE:   09.05.2007

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. provisions.

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