Wednesday, 13 November 2019
Regulations and Determinations
Gene Technology Amendment (2019 Measures No. 1) Regulations 2019; Disallowance
That the Gene Technology Amendment (2019 Measures No. 1) Regulations 2019, made under the Gene Technology Act 2000, be disallowed [F2019L00573].
This is a Greens motion to disallow the Gene Technology Amendment (2019 Measures No. 1) Regulations 2019, and I call on senators to support this motion. It is vital that we do so in order to protect our multibillion dollar agricultural export industry and the clean, green reputation of Australian agriculture.
The amendments to the gene technology regulations we're seeking to disallow will deregulate the use of a range of new genetic modification techniques in animals, plants and microbes. We fear these changes will have profound impacts on Australia's agricultural exports. This deregulation is reckless and poses huge economic risks to Australia's $48 billion agricultural export industries. It could potentially kill our organic farming industry and massively hamper our traditional agricultural export industry too. Potentially, vast amounts of Australian produce currently guaranteed to be free from GMOs will no longer be so. This is because deregulation means there'll be no tracking of the production or the release of genetically modified organisms created using SDN-1 technology. There'll be no ability to say whether these organisms are present or absent in produce. We will just not know. This is being done without considering the potential dire impacts of this change, the impacts of losing this GMO-free status.
I'd like to quote from a letter from the former South Australian Minister for Agriculture, Food and Fisheries which was submitted as part of a consultation process about this change:
South Australia's non-GM position provides our agricultural producers and food businesses market access in countries where there is demand for non-GM products or products made with non-GM ingredients … our non-GM status is one of the elements which underpin our global reputation as a supplier of premium food and wine from our clean environment.
Similarly, in a media release in support of this motion, Organic Industries said:
The organic industry urges all Senators to overturn the Government's deregulation of gene technology. Instead, the Government should consider a proper risk assessment and cost-benefit analysis.
The Office of the Gene Technology Regulator assessed this deregulation on a scientific and health basis. But it paid no consideration to the market impact of this deregulation, nor has it properly consulted with the farmers whose livelihoods will be affected. The regulation impact statement that was undertaken by the Office of the Gene Technology Regulator was completely inadequate, with extraordinary and wilful disregard for the risk to billions of dollars of exports.
This is what the impact statement had to say about potential impacts on our exporters:
In this context, non-alignment between Australia and some trading partners appears likely, regardless of the direction of the Technical Review or further developments resulting from the Scheme Review. In the event this occurs, industry would have access to the same mechanisms used to resolve non-alignment issues for other aspects of trade.
The lack of concern for what they describe as 'non-alignment' is gobsmacking. Non-alignment means our produce will not be able to be certified as being GMO-free in our major export markets. I'm sorry, but the same mechanisms used to resolve non-alignment issues for other aspects of trade will not put the GMO genie back in the bottle, as much as the OGTR may wish and pray it will be able to do so.
Our farmers deserve better than this. I spoke with many organic stakeholders who told me loud and clear what 'non-alignment' means to them. For example, I met with an organic wine producer in regional South Australia. He told me about the challenges of guaranteeing that his produce is GMO free. If a genetically modified strain of yeast gets into his wine production, he told me, that will be it. It'll be all over. It will be impossible to remove it. The risk that this has occurred—and he won't know whether it's occurred, because it's not being tracked or monitored—will make it impossible to guarantee that his produce is organic, which means he will not be able to reap the benefits of marketing his wine as organic, GMO-free, quality Australian wine. He told me about the challenges he faces already in ensuring that he can access international markets, working through the Department of Agriculture's processes to ensure that Australian standards match up with the export markets he's trying to sell into, and he says that at the moment he just does not bother to try to sell into markets where there isn't that alignment. It's just too hard. So he is distraught about what the impact of this deregulation is going to be on his business and that no-one has even bothered talking to him about it.
Another example of contamination relates to grasses and weeds. I would like to read a quote from the National Association for Sustainable Agriculture Australia in a media release they put out in support of this disallowance motion. They said:
Just one example involves rye grass, a common pasture feed, but in horticulture it is a noxious weed that spreads rapidly. Should a GMO rye grass be released, it could contaminate the entire country in a few short years.
But we just wouldn't know whether it's occurred, because no-one will be tracking it and it's impossible to test for these gene edited organisms.
Proponents of this deregulation argue that, because the mutations that are created using SDN-1 technology are indistinguishable from natural mutations, the technology is therefore safe. On that point, I would like to read a quote from Professor Heinemann of the University of Canterbury. He says:
There is a profound difference between what has been genetic engineering using the techniques originating in the 1970s, and which are responsible for the majority of the world's commercially available genetically modified plants, and the genetic engineering that can be done with SDN-1 and dsRNA to any kind of organism. A key difference is that these tools can be liberally used outside leading to simultaneous exposures of all species present. Not just the products of these techniques, but the dsRNA and the editing proteins can be applied at landscape scale out-of-doors by people with very little skill and no or limited knowledge of what the modifications might do.
We won't be tracking them. We won't be monitoring them. They will not be regulated. Crucially, Professor Heinemann says:
Applications of the SDN-1 technique can lead to modifications to genes or other genetic materials as different as can the treatment with DNA from other species. This is due to the ability to apply them rapidly and repeatedly to the same target area in a genome or to apply them simultaneously to many areas of a genome. Even if all the places damaged by a nuclease are repaired by a "random" process, the cumulative scale of change in sequence would be no different, possibly even larger, than the differences created using transgenic genetic engineering. There is no evidence of which I am aware that other mutagenesis techniques can do this to the same extent and preserve the viability of the modified organism.
One of the arguments that have been put forward as to why this change is necessary is that it's needed to facilitate medical research, but, first-up, remember we're not saying that SDN-1 technology should be banned; we just want the status quo to remain so that these technologies are regulated and their use is tracked. In contrast to what some may say, there's no consensus amongst medical researchers that deregulation is needed. In its 2016 consultation paper, the Office of the Gene Technology Regulator put forward a number of options. Option 1 was for no change to the regulations, which would have kept SDN-1 technologies captured under the regulations.
The Walter and Eliza Hall Institute of Medical Research submitted that they supported option 1 as it pertained to new technologies. Furthermore, they wrote:
We see no benefit, and perhaps a risk, …
That's with other options, including the current deregulatory approach. Similarly, the Victoria University Institutional Biosafety Committee wrote:
More evidence is needed on all the risks and potential benefits of the new gene technologies and their products, so the Precautionary Principle … should apply.
Likewise, the Children's Medical Research Institute wrote:
Given that CRISPR and other site-directed repair mechanisms all use a directed and targeted gene editing strategy we believe that these technologies should be regulated, even though the mechanism underpinning the technology is a natural repair mechanism.
But I want to finish by returning to the huge risk that this deregulation poses to our agricultural export industries and reiterating the likelihood that organic regulators locally and internationally will decide that, since Australia has deregulated this technology, none of our produce can be guaranteed to be free from genetically modified organisms. This will mean that farmers will lose their organic certifications, and without those certifications the organics industry will collapse.
Europe already says that these new technologies are genetic modification technologies, so the risk is that, unless we disallow this regulation, countries such as China and the countries of the European Union could reject our exports. The government and the Labor Party have said that because the states have signed up on these changes they should go ahead, but I question how well informed the states are in their support for deregulation. How practical is it going to be to maintain a state based moratorium, such as Tasmania says it's going to do, when no-one is tracking these organisms?
Our national government spends millions on ensuring biosecurity at the national border, facing challenges like African swine fever. Are the states well enough resourced to track organisms that have no registration and that are not being tracked or monitored? It is ludicrous to think that this is going to occur. Tasmania recently extended its GMO moratorium for a further 10 years, but they will not be able to remain GMO free when these GMO organisms are being produced and distributed across the country, unregulated and untracked.
Australian agricultural exports to China alone are a nearly-$12-billion industry, covering a huge sweep of agricultural commodities. So there is huge concern that farmers are going to lose access to these export markets, and the government has not allayed these concerns. What is the reason for the government feeling the need to rush this through? Why is the ALP supporting the government in doing this? It seems to me like a pretty clear-cut case of the excessive influence of big business—in this case, the big biotech companies. They are the ones who are going to benefit from this deregulation. They are the ones with the patents on the technologies. They are the ones who make the big donations to both the Liberal and Labor parties and who have platoons of lobbyists here at Parliament House to keep currying favour.
The Greens believe that the safe and prudent thing to do is to continue to treat the new technologies like the other genetic technologies covered by the Gene Technology Act. It is absurd that that's not going to be the case. We're not talking about imposing new regulations or obligations on these technologies, and we're not talking about stopping the use of these technologies. We're simply asking to retain the status quo and to keep them under the existing regulatory regime.
The Senate must disallow these changes in order for a proper examination of the issues at stake here to proceed. We need to understand what impact this will have on our organic farmers, on our farmers who benefit from being GMO free and on our broader communities.
Very briefly, I'd just like to put the government's position on the record, which is of course to oppose the disallowance motion. In saying that, Australia has a very robust gene technology regulatory system to ensure the safety of the Australian population and, of course, our environment.
The changes do not compromise these highest of priorities. Compared to other countries, Australia takes a very cautious, rigorous and science-based approach to regulating gene technologies. These amendments to the Gene Technology Regulations were approved by the states and territories at the ministerial forum earlier this year to ensure that Australia continues to keep up with rapidly evolving technology. Without these amendments, legal uncertainty will remain. These updates strengthen regulations for the vast majority of gene-editing techniques which must undergo stringent safety assessments.
The updates will provide great benefits in the area of medical research. Medical researchers will be able to move more quickly through the concept work, and progress to clinical trials with patients. These changes will support life-saving medical research to create the medical treatments of the future. The Association of Australian Medical Research Institutes today publicly supported the government's amendments.
The updates were made following extensive consultation and are supported by the leading Australian research institutions. Agricultural industry groups and the medical research sector strongly supported the amendments regarding SD1.
Labor does not support this motion, which will disallow the first amendments to Australia's Gene Technology Regulations in nearly 20 years. The amendment is necessary to take account of the changes since the existing list of genetically modified organisms was set out in 2001. The amendment recognises the development of science since then. The disallowance motion does not acknowledge the developments in science. It reflects the fear and the misunderstanding that some people have about genetic modifications.
I am listening—very much so. It is strange that some people who might be happy to endorse the science on climate change show less regard to the scientific evidence and the rational inquiry on other matters such as gene technology. Genetic modification is a term which, of course, in some quarters, causes great alarm, but it is a name for progress that humans have been engaged in for many thousands of years. It's the history of agriculture, which has long involved genetic modification. It's the process of altering organisms' genetic make-up, and, of course, it happens in the selective breeding of plants and of animals. It is how drought-resistant and pest-resistant crops have been developed. It is how the nutritional yields of foods have improved enormously. GMs take place in the laboratory rather than in the paddock. It is a principle no different from what has happened in selective breeding. What we have here is more precise than the traditional methods have been, in terms of similar goals.
In much more than 20 years of commercial use, the scientific consensus is that GM techniques have posed no greater risk to human health or the environment than similar products derived from traditional breeding or selection processes. That's the scientific consensus—and I'm referring to the assessments from the World Health Organization, the Royal Society of London and the United States National Academy of Sciences. There is no natural order that is being destroyed or disrupted. There is no Dr Frankenstein's monster that is being fabricated. There are no monstrous creatures being created in the dead of night.
What we have here is the situation where humanity, for centuries, has been developing better products, and, of course, better strains of food and of animals, and that is still the case. The difference now is that modern technology gives us the capabilities that selective breeding in the past had not. In modern GM technology, gene functions can be added, deleted or turned off. Specific genes that determine particular traits can be implanted into another organism. That is then referred to specifically as a genetically modified organism.
That occurs not just in agriculture. That's the situation that occurs in medical advances, where the progress has been absolutely enormous. GM technology has been used to produce new vaccines, new antivenenes and new antibodies. Insulin, used for the treatment of diabetes, has been synthesised using GM bacteria. People ask, 'What's the use of this stuff?' Insulin! It's not just the major pharmaceutical companies that benefit from insulin; it's hundreds of thousands of Australians that benefit from the medical advances that come from this science! As to the product of insulin, I suggest that there might be a few senators that use this stuff every day.
You are saying that. You are saying exactly that.
This process is significantly more efficient than the previous methods, which involved the extraction of animal insulin from cows and pigs. This process saves lives. It's appropriate that we ensure the proper regulation of scientific processes through the Therapeutic Goods Administration, just as we do with food, through Food Standards Australia New Zealand, and various organisms, through the agriculture organisations of the UN. Gene technology is a regulated process, and ensuring human safety is one reason that you have to have proper regulations in place. That's why regulations need to be revised from time to time to take into account new developments. The new regulations that Senator Rice, I'm sorry to say, is seeking to have us ignore are overseen by the Office of the Gene Technology Regulator. They are regulations which classify organisms classified by immune technologies as GMOs. They exclude the GMO organism SDN-1. That is because the regulator found that SDN-1 organisms are indistinguishable from naturally occurring genetic changes and present no higher risk.
The exclusion has been the subject of campaigns by Friends of the Earth and other groups who have a moral objection to GMOs. They have a moral objection to the use of science in this way. They claim that SDNs have not been proved to be safe and there could be unintended consequences for the food supply, animals and the environment. Well, the regulator has responded. There is no evidence that SDN-1 is harmful. I repeat: these organisms are indistinguishable from organisms that occur naturally. The food supply will not be disrupted. It will continue to be regulated by the Australia New Zealand Food Standards Code. If this disallowance motion is passed, it will put at risk and impose quite dangerous restrictions on the ability to regulate properly. It will undermine the capacity for research and development. It will undermine the capacity for innovation, particularly in regard to medicine. SDN-1 techniques, which include the CRISPR technology, are crucial to the development of new cancer treatments and vaccines. Who do they benefit? They benefit Australians. They benefit hundreds of thousands of Australians.
There are echoes here of what we hear from some quarters about the development of nuclear technology for medical purposes. Of course, the people concerned are only too happy to enjoy the benefits of radiopharmacology when they get cancer. We have to ensure that their advice is not followed when it comes to an action such as has been proposed by Senator Rice. We need to take into account the danger to future medical innovations that the passing of this disallowance motion would create, because this attitude to GMO is formed not on the basis of evidence but on the basis of prejudice. The fundamental proposition advanced is that there is a moral objection to this science. We hear it, for instance, from the National Association for Sustainable Agriculture, who say, 'GMOs of any kind and organics simply don't mix.'
We just heard it there. 'And they don't,' says the senator. The assertion is simply false. They do mix and they have done so for a very, very long time. The fact is they save lives and they produce food for hungry people. This is not science fiction and it's certainly not the fantasies that are pedalled by those who support this disallowance motion. This is real science, which is why the new regulatory framework has been supported by the Australian Academy of Science and the Australian National University. It is why it's supported by industry bodies such as the Grains Research and Development Corporation. It is why the Office of the Gene Technology Regulator rejects the assertion of Friends of the Earth that the regulations will undermine Australia's status as a world leader in organic food production. It rejects it because it's simply not true. The regulator stated:
They've simply got the facts wrong. In calling for the revision of the regulations that were adopted in 2001, the Academy of Science argued this:
The Australian regulatory framework for gene technology was established at a time when the technology was new, the risks were poorly defined, and there were few commercial products. Consequently, the focus was on ensuring the safety of new work in research facilities and tightly controlled small scale trials.
… … …
The Academy takes the position that there are efficiencies to be gained in the legislative and regulatory framework by developing an exemption model for organisms with genetic modifications indistinguishable from those produced by non-genetic modification techniques …
The Academy also recommends a regulatory scheme that is able to adapt to new technological developments, through clear definitions that focus on research outcomes rather than the technology used to achieve them.
The new regulations that Senator Rice and the Friends of the Earth are seeking to overturn do what the academy recommended. Senators should reflect carefully on the advice when they vote on this motion. Does the Senate want to take an evidence based approach to decisions on gene technology, an approach that reflects the development of techniques in genetic science over the last two decades, developments that will continue to allow appropriate regulations to protect human safety, or do we want to succumb to the ideological resistance to genetic technologies being pushed by organisations like Friends of the Earth? If we want to build an enlightened future for this country, a future that does not reject science, we should reject this motion. The new gene technology regulations should be upheld.
Centre Alliance will support this disallowance, because we are not convinced the SDN-1 gene-editing technique should be excluded from regulation. While it is a low-risk technique, we accept there are potentially significant trade impacts relating to the new regulation for Australian exports to nations with stricter regulatory regimes, especially for organic and non-GMO marketed products. We note that the most recent decision from the European Court of Justice affirmed that all SDN techniques, including SDN-1, are considered to be genetic modification techniques and, as such, are required to be regulated under the obligations of the EU's GMO directive. We also note that Tasmanian Premier Will Hodgman and Tasmania's Minister for Primary Industries and Water, Guy Barnett, have both said that the state will specifically regulate the use of SDN-1-modified organisations in order to protect Tasmania's GMO-free reputation.
I never thought I would rise in this place and say that I support 100 per cent the contribution of Senator Carr. I really never thought I would rise in this place and say this. I doubt I'll ever say it again, but it's good to be able to say it at least once, Senator Carr. I certainly will not cover the territory that you have covered. I probably would have said it in slightly more moderate tones, but I agree with everything that you stated. We face in this country a need to improve agricultural productivity. We're currently in the midst of drought, particularly on the east coast, though there are also some issues in Western Australia. We're seeing international competition from trading partners into what we once considered our natural markets. We're seeing productivity not increase at the pace we need it to to meet the world's demand for food and fibre. In order to achieve these things, we need a fourth agricultural revolution. We need a new green revolution—not the sort of green revolution that's indicated by the political party but a green revolution in terms of our productivity. We need to embrace techniques such as these genetic modification techniques in order to supply the world with the food and fibre it needs going forward.
I will just raise not the techniques covered by these regulations but some of the older genetic modification techniques that have been used so successfully in the cotton industry. They reduced pesticide usage in cotton crops by 90 per cent. You would think that the Greens would be jumping up and down and celebrating the reduction in the use of pesticides by 90 per cent. But, because of the ideological campaign against these techniques, against genetic modification in principle, we see them argue against it. There has been much raised of risk to the international trading environment. I will point out, in the very few seconds I have remaining, that Argentina, Brazil, Chile and the United States have all excluded SDN-1 from the scope of their regulation, and a number of other countries are doing the same.