AustLII Home | Databases | WorldLII | Search | Feedback

University of New South Wales Law Journal Student Series

You are here:  AustLII >> Databases >> University of New South Wales Law Journal Student Series >> 2021 >> [2021] UNSWLawJlStuS 4

Database Search | Name Search | Recent Articles | Noteup | LawCite | Author Info | Download | Help

Gore, Matthew --- "Genetically Engineered Animals As Food: A Regulatory Framework Under-Prepared" [2021] UNSWLawJlStuS 4; (2021) UNSWLJ Student Series No 21-4


GENETICALLY ENGINEERED ANIMALS AS FOOD:

A REGULATORY FRAMEWORK UNDER-PREPARED

MATTHEW GORE

Using traditional breeding techniques, humans have farmed – and consumed – genetically modified organisms for thousands of years. However with the advent of modern genetic engineering in the 1970’s, and sophisticated genome editing techniques in the last decade, we have witnessed a rapid development in the complexity and capabilities of these genetically modified organisms. Whilst genetically engineered plants are now common in farming practices across the globe, we have not observed reciprocal proliferation of genetically engineered animals in agriculture to date. In fact, at the time of writing, there are no recorded cases of a genetically engineered animal being released to market for consumption as ‘food’ anywhere in the world. However, this appears likely to change in the near future, with the recent approval of genetically engineered salmon for sale in the US. This essay will examine a range of legal implications of admitting such genetically engineered animals in an Australian context. Part I will provide an overview of genetically engineered animal ‘foods’, and Part II will examine the legal implications of regulating these as a ‘technology’. In particular, it will conclude that genetically engineered animals are appropriately regulated as a scientific technology, and fall within the ambit of patentable subject matter, however ancillary issues may arise regarding inadvertent patent infringement and access to privatised genetic resources. In turn, Part III will investigate the legal implications of admitting genetically engineered animals as ‘food’, examining food regulations, statutory labelling regimes, and bioethical issues such as animal welfare and agricultural co-existence. In contrast, it will conclude that each of these legal regimes are inadequately designed to facilitate genetically engineered animals and require significant reform to ensure inconsistencies and injustices do not arise in the future. Consequently, whilst the regulatory frameworks are reasonably equipped to address genetically engineered animals as ‘technology’, they currently fail to effectively regulate them as ‘food’. These inadequacies must be addressed before there can be widespread adoption and market-penetration of genetically engineered animals as food in Australia.

I AN INTRODUCTION TO GENETIC ENGINEERING AND FOOD

The wide-spread development and industrial adoption of genetically modified organisms (GMOs) remains extremely controversial. This debate stems from the potential of GMOs to address issues of food security, environmental sustainability and provide other perceived economic benefits, counterposed by potential threats to biodiversity, long-term agricultural productivity, and human health.[1] Whilst this debate traditionally revolved around breeding practices used to optimise crops’ phenotypic traits, in recent years it has become focused on genetically engineered (GE) animals in which the genotype has been directly altered using molecular techniques. However, with the advent of precise genome editing techniques such as CRISPR-Cas9 in the last decade, it is arguable this distinction has become blurred.[2] For example, rather than the late-twentieth century practice of introducing entirely new genes into the unfertilised egg or embryonic stem cells, CRISPR-Cas9 can precisely ‘slice’ out a targeted section of DNA which is then repaired through non-homologous end-joining of the original DNA strands, or by the guided insertion of new DNA.[3] The end result is a precisely designed GMO, genetically identical to the GMO produced through generations of imprecise cross-breeding. As seen in Parts II and III, this has raised questions over whether more recent GE animals can, and should, be regulated in the same manner as those developed through older technologies.[4]

GMOs can be broadly categorised as ‘red biotechnology’ with pharmaceutical applications, or ‘green biotechnology’ with food applications.[5] Here, it is noted that ‘food’ carries a legal rather than scientific meaning, and simply refers to any substance or thing used for human consumption.[6] The focus of this essay, ‘green’ GE animals are typically designed for increased productivity, including modifications to increase growth, the quality of their products, or to confer disease resistance.[7] Two examples of green GE animals that will be drawn on as case studies throughout this essay are AquAdvantage Salmon (AA Salmon) and EnviroPig.

AA Salmon are GM Atlantic salmon possessing a growth hormone gene construct inserted from Chinook salmon, leading to a 3x faster growth rate.[8] Despite only ~20% of the population supporting faster-growing GM fish,[9] in 2019 the US Food and Drug Authority (FDA) approved the sale of the patented AA Salmon within the US.[10] It is pertinent to note however that it was approved as an animal drug, rather than ‘food’.[11]

In contrast, EnviroPig – discontinued in 2012 due to program funding cuts – was designed with environmental considerations rather than productivity in mind.[12] EnviroPigs were modified to produce enzymes allowing them to efficiently digest phosphate from supplemented feed,[13] as well as secrete up to 75% less phosphorous – the release of which constitutes an ‘enormous environmental problem’.[14]

Public sentiments towards GMOs such as AA Salmon and EnviroPig vary significantly depending on geography and use. For example, an extensive meta-analysis identified that attitudes were more negative towards green GMOs than red GMOs, and towards GE animals compared to GE plants.[15] Similarly, a 2017 national survey commissioned by the (Australian) Office of the Gene Technology Regulator (OGTR) found 63% support for GMOs in medical uses, but only 38% support for food and crops.[16] These percentages may even be lower on a global scale, as Australia and the US are considered favourable towards GM products when compared to regions such as the EU.[17]

A Food Security – A Need for Genetically Modified Organisms

Despite general consumer aversion to GE animal foods, Pariza argues that the majority of plant species we eat are substantially ‘weakened genetically’ to allow for qualities of taste, palatability and nutrition.[18] This includes both fundamental changes to the ‘nature’ of the plant, such as size and plant architecture,[19] as well as minor cosmetic changes like colour shade. Although there are many reasons this has occurred, a particularly pertinent one is the concern over food security.

Food security is defined by the UN as the ability at all times to have physical, social and economic access to sufficient, safe and nutritious food.[20] This is threatened by population growth, with the world population anticipated to reach 9.7 billion – and demand for food increase by 60% – by 2050.[21] Contributory factors also include the loss of arable land at a rate of approximately 1 million hectares per year,[22] and large-scale cultural shifts in low-income countries to more resource-intensive Western diets.[23] In response, the US National Intelligence Council identified transgenic technologies as the most promising option for achieving food security in the next 20 years.[24] This is a contentious conclusion however, with authors such as Greger arguing the ‘productionist paradigm’ of ‘more is better’ underpinning GMOs does not necessarily equate to food security,[25] and Altieri and Rosset highlighting the profit-driven rather than need-driven nature of biotechnology, as well as increased costs for farmers for no greater yield.[26]

Notwithstanding the above, the author proposes the importance of GMOs to food security is evinced by the positive attitudes demonstrated towards them in low-income and Asian countries.[27] As Bongoni states, “choices that the poor from these nations have is either to starve and ultimately die or to be fed and therefore, they seldom debate on quality or source of food production”.[28] This is in contrast to the anti-GMO stance of economically stable European nations where movements such as Slow Food and gastronomic dining originated, and, for now at least, issues of ‘food sovereignty’ are prioritised.[29]

II GENETICALLY ENGINEERED ANIMALS AS ‘TECHNOLOGY’

As products of scientific techniques and technologies, GE animals fall under two key legislative frameworks. The first is that of the gene technology regulatory scheme, which determines whether proposed GE animals can be produced or used in any capacity in Australia. The second is the national patent regime, without which biotechnology companies will not produce GE animals as a matter of commercial practice.

A Gene Technology Regulatory Scheme

Molecular technologies and genetic engineering techniques, both in research and commercial applications, are heavily regulated around the globe. This is particularly important in the context of GE animals, as consumer trust and confidence in regulatory institutions is one of the most significant factors influencing positive attitudes towards GMOs.[30]

In Australia, the genetic modification of organisms is regulated under the Gene Technology Act 2000 (Cth) (GT Act) and the Gene Technology Regulations 2001 (Cth) (GT Regulations). With a presumption in favour of facilitating biotechnology,[31] the GT Act regulates all GMOs within Australia – seeking to identify and manage the associated risks in order to protect the health and safety of people and the environment.[32] The scheme has a ‘process trigger’, meaning it is enlivened by any process using ‘gene technology’ to modify an organism (the legislative definition of a ‘GMO’).[33] Whilst a number of authors point to ambiguities in this definition,[34] an analysis of which lies beyond the remit of this essay, it is uncontroversial that ‘organism’ includes animals, and ‘gene technology’ is broadly defined to capture any technique for the modification of genetic material.[35] Nonetheless, it is interesting to note that it is unclear whether an exemption to the GMO definition would apply under Schedule 1 of the GT Regulations if GE animals such as AA Salmon and EnviroPig were produced using SDN-1 gene editing techniques to merely cut the DNA strands, with subsequent non-homologous end-joining but no introduction of exogenous DNA.[36]

As GE animals fall within the definition of ‘GMO’, the GT Act establishes a blanket prohibition on any dealings with them in Australia unless they are specifically authorised.[37] GE animals will only be authorised under licenced dealings,[38] which requires a risk-based assessment of the GE animal as a product.[39] Amin et al. defines risk as ‘the probability that injury, danger or damage will result from the uses from the substances in the proposed quantity and manner’.[40] In this case, the GTR is assessing the probability of injury, danger or damage to the health and safety of people, or to the environment, from the farming and consumption of GE animals as food products.[41] This assessment then requires a comparison to the risks posed by the equivalent use of the respective non-GE animals; if the risks posed by a GMO are no greater, it is likely to gain approval.[42] Interestingly, several authors criticise the risk-assessment for omitting reference to the ‘precautionary principle’ that ‘acknowledged scientific uncertainty should not be used as a reason to postpone preventative measures’;[43] the ‘highpoint’ of the Cartagena Protocol on Biosafety.[44] Furthermore, other elements of the assessment have come under critique. For example, Tsui argues that the assessment fails to adequately protect and conserve biodiversity due to a narrow definition of ‘environment’.[45] Additionally, Wickson claims that scientific knowledge dominates the risk-based assessment and there is no scope for public participation or consideration of ethical or social issues.[46] Thygesen further supports this sentiment when he argues that the assessment does not allow consideration of other important issues such as benefits or product efficacy.[47] However, a likely counter-argument is that this can and should be left to market forces.

Notwithstanding the above criticisms, it is clear the GT Act anticipates GE animals such as AA Salmon and EnviroPig, and is equipped with the regulatory powers to authorise them for commercial use under licenced dealings. In light of the assessed risks for each GE animal, these licences may impose particular conditions or restrictions,[48] and typically require the use of accredited containment facilities.[49] Barring some legal uncertainty around SDN-1 exemptions to the GT Act, the mass development of GE animals therefore poses no legal challenges or implications for the existing legislative framework. Whilst this is a nationally consistent outcome under the GT Act, it is important to note that certain states have nonetheless introduced a moratorium on GMOs unless also authorised under State legislation.[50] These moratoria differ on which exact GMOs they prohibit, and currently exist in the Australian Capital Territory (indefinitely), South Australia (until 2025) and Tasmania (until 2029).[51] Consequently, whilst biotechnology companies may receive licenced authorisation for GE animals under the GT Act, the domestic location for production, use and sale is a vital commercial consideration.

B Australian Patent System

Whilst GE animals can be legally produced and sold without the protection of a patent, to do so would be contrary to commercial practice. This is because patent ownership conveys a ‘negative’ monopoly right to prevent other parties from manufacturing, using, or selling the patented product for 20 years,[52] which is critical for biotechnology companies to recoup their considerable research and development investments. Whilst the legislative regime is therefore purposed as an ‘instrument of national economic policy’ to stimulate and incentivise innovation,[53] some authors conversely argue that a proliferation of patents leads to a ‘tragedy of the anticommons’ that stifles further research and innovation.[54] It is generally agreed however that for biotechnological products, patents play a significant role in legitimising and stabilising the product as a worthwhile investment.[55]

There is considerable academic debate as to whether the patenting (often inaccurately conflated with ownership) of genes or GMOs is ethically acceptable. However, this essay seeks to address whether GE animals can be patented; not whether they should be. Australian patent law is governed by the Patents Act 1990 (Cth). In particular, GE animals can be patented if they fall within the definition of ‘a manner of manufacture’.[56] The first case to deal with the interpretation of this phrase in the context of GMOs was heard in 1980.[57] In Diamond v Chakrabarty, not only was it held that a GE bacterium was patentable subject matter, but that ‘anything under the sun that is made by man’ could be patented.[58] Australian courts have endorsed this decision, although not quite to the extent expressed by the US Supreme Court – for example, biological processes for the generation of human beings are not patentable inventions in Australia.[59] Consequently, a large number of GMOs are currently the subject of patents registered with IP Australia. Active patents for red GE animals include mice with a modified major histocompatibility complex (for immune system research) (application number: 2018201402) and pigs modified for xenotransplantation (application number: 2017202389). In addition to receiving patent protection in the US, it is thus almost certain that green GE animals like AA Salmon and EnviroPig would be patentable under Australian legislation. As there are further requirements for patent validity,[60] this is not to say that the patents would be granted automatically, nor go unopposed following publication – merely that they would not be rejected on the basis that GE animals are not patentable subject matter.

Whilst GE animals therefore fall squarely within the patent regime and do not raise any legal implications in an immediate sense, interesting ancillary implications nonetheless arise when GE animals are considered as a patented product.

Firstly, a number of farmers have voiced concerns over inadvertent patent infringement should their crops become contaminated by the patented genetic material from neighbours’ farms. These concerns are valid given the aggressive litigation history of large biotechnology firms such as Monsanto against small individual farmers.[61] Indeed, it has been reported that Monsanto even researched the possibility of engineering traits into its plants ‘such that their leaves would reflect light in a characteristic way’ and be visible by satellite – purely for the purpose of regulating patent infringement.[62] Reflecting these fears, a collective of farmers’ organisations in the US sued Monsanto, (unsuccessfully) seeking a declaration that they would not be sued for patent infringement if their crops were contaminated.[63] Whilst this played out in the context of GE plants, there is no reason the same would not occur with GE animals that escape containment and breed with a neighbour’s livestock. In Australia, lack of knowledge is not a defence to infringement. Whilst the neighbour may argue ‘innocent infringement’, under which the Court may refuse to award damages, they would have to establish that they were not aware, nor had a reason to believe, that the patent over the GE animal existed.[64] Satisfying such an evidentiary burden would be extremely difficult. To thus address a likely future of extensive litigation against third-party farmers with no control over the patented GE animals, one solution may be the introduction of a statutory defence to infringement when the defendant’s livestock has been unknowingly contaminated by the GE livestock of the respective patent licensee.

The patenting of GE animals may also lead to the increasing privatisation of these genetic resources,[65] such that smaller and poorer farmers are unable to access GE livestock. Given the profit-driven rather than need-driven nature of biotechnology companies,[66] this has the potential to drastically undermine food security (and thereby one of its own leading justifications). However, this socio-economic challenge may have a legal resolution, with statutory licencing regimes of GMOs to farmers implemented and subsidised by the Federal Government. Alternatively, patents may be acquired by the public sector and the products distributed freely, as seen with insect-resistant Bt brinjal (eggplant) in Bangladesh.[67]

III GENETICALLY ENGINEERED ANIMALS AS ‘FOOD’

As a food product available for general consumption, GE animals fall under further regulatory regimes. However, these generally deal with non-GMO food products and appear less suitably adapted to GE animals. Part III will first consider the overarching food regulation within Australia, and subsequent labelling requirements. It will then turn to conclude with an examination of the legal implications flowing from the key bioethical issues arising from the use of green GE animals.

A Food Standards Regulation – Food or Something Else?

Food products derived from GE plants are regulated under the Australia New Zealand Food Standards (the Code). It is generally assumed that food products derived from GE Animals would also fall under the Code, however this is not certain given the list of approved ‘GM foods’ thus far only contains plant-derived foods.[68] Furthermore, the Code does not define ‘food’; rather referring the definition to whatever is used in the particular legislation applying the Code.[69] However, despite the potential inconsistencies thus arising in the various definitions of food, it is still likely to include GE animals. This is indicated by a relevant Note in the Code stating that the various definitions ‘all have a similar effect and make the concept very broad, effectively covering anything that is intended or offered for human consumption’.[70] This is essentially the same as Pariza’s ‘legal meaning’ of food adopted in Part I,[71] and despite the small level of legal uncertainty, would strongly indicate that green GE animals will be regulated as ‘food’ in Australia. This is in contrast to the stance taken in the US by the FDA which defines and seeks to regulate AA Salmon as a ‘drug’.

Similarly to the GT Act, the Code operates to prohibit the sale of GMOs as food unless expressly authorised.[72] Whilst the Code adopts the same process-trigger and language of ‘food produced using gene technology’, the definition is narrower and limited to ‘recombinant DNA techniques’, which is undefined.[73] A 2019 review of the Code by Food Standards Australia New Zealand (FSANZ) found this term, which means ‘recombining or joining DNA from two different sources’,[74] was introduced 20 years ago and ‘intended to capture the types of GM food products that existed at the time’.[75] As such, whilst it would capture GE animals like AA Salmon and EnviroPig, any GE animals produced through SDN-1 or even CRISP-Cas9 techniques that do not introduce exogenous DNA from a different source would not be captured by the Code’s prohibition. It is also interesting to note FSANZ’s recognition that advanced gene editing techniques such as CRISP-Cas9 – referred to in the report as New Breeding Techniques (NBTs) – can precisely mimic conventional cross-breeding and classical mutagenesis techniques.[76] As these conventional techniques are not captured by the prohibition, FSANZ indicated there may be a case for excluding some NBT-derived GE animals from the prohibition if they are equivalent in characteristics to conventional food.[77]

For GE animals captured by the Standard 1.5.2 prohibition, such as AA Salmon and EnviroPig, approval requires a further pre-market risk-based assessment conducted by FSANZ. Typically, if the GMO is determined to be at least as safe as its traditional counterpart, then it is approved.[78] This would take the form of the GE animal’s listing as a ‘permitted food’ in Schedule 26 of the Code,[79] along with any special conditions imposed on the sale of the food product.

Whilst it can be therefore seen that the Code anticipates GE animals as foods, significant legal implications arise from its outdated drafting. Following FSANZ’s report of 2019 it is anticipated that the Code will soon be updated to ensure capture of GMOs produced through newer non-recombinant technologies. However, until this occurs it is likely that any GE animal produced using techniques such as SDN-1 will not require a risk-based assessment before going to market.

B Labelling Requirements

An equally controversial aspect of the GMO debate is whether GMO food products should be subject to mandatory labelling requirements. As consumers are unable to determine whether GE animals contain particular qualities through searching or experience alone, they are considered credence goods.[80] For credence goods – not GMOs specifically – labels are generally believed to play a ‘significant role in facilitating consumer choice’.[81] Before examining Australian legislative requirements, this essay will briefly consider the labelling debate – drawing on the underlying arguments from the opposing US and EU positions.

In the US, GMO labelling is not mandated by Federal legislation. Instead, the FDA adopts the position that the information on a food label should be useful regarding consumers’ nutrition and health decisions.[82] As such, GMO labelling could be mandated, but only if it potentially posed a health risk to some of the population – in which it would be unlikely to receive approval in the first case. This reflects the position of a number of academics who argue that labelling implies the unfounded conclusion that the product is unsafe.[83] It also reflects the findings of the Australian Productivity Commission, which stated that ‘the case for mandatory labelling ... is weak’, given that FSANZ already assesses GM foods for their health and safety.[84] Labelling is therefore a consumer value rather than a food safety issue.[85] However, the author proposes that labelling can have a positive effect simply for its consumer value. For example, meta-analysis by Frewer et al. revealed that ‘labelling and consumer choice emerged as an important issue in relation to food in all regions where data were available’.[86] Furthermore, the FDA’s position ignores ‘right to know’ and ‘consumer autonomy’ principles.[87] Perhaps as the strongest example of actions speaking louder than words, in the case of AA Salmon, AquaBounty plan to label their products in the US, citing their ‘commitment to transparency’.[88] Such a position is endorsed in the EU, where the labelling of GM products is mandatory. This may also be a manifestation of underpinning policies in the EU such as the precautionary principle and food sovereignty.[89] In further support of mandatory labelling, studies demonstrate that about one-third of consumers see GE labels, and for just over 50% of these consumers the label provides information upon which their decision to purchase GE-containing or GE-free foods is based.[90]

Like the EU, Australia has adopted a mandatory food labelling scheme – with a few limited exemptions. Under the Code, there is a blanket requirement to label ‘genetically modified food’ as ‘genetically modified’.[91] However, genetically modified foods are defined as food ‘produced using gene technology’ that contains novel DNA or novel protein, or is listed in Schedule 26 as subject to labelling requirements.[92] As this adopts the same out-dated definition previously discussed (pursuant to the 2019 FSANZ report), it is unlikely mandatory labelling requirements would capture the same category of GE animals produced through more recent molecular technologies. Therefore, unless GE labelling requirements were imposed as licence conditions under the GT Act,[93] this may have the bizarre effect of allowing certain GE animals to proceed directly to market without a FSANZ risk-based assessment or any labelling obligations.

C Bioethical Issues

Beyond these implications for key regulatory frameworks, increased market-penetration of green GE animals raises a number of significant bioethical issues with corresponding legal implications. Consideration of these is important as good bioethics ensures scientists do not operate in a vacuum, but instead engage with diverse values and perspectives to spur progress.[94] This is particularly the case in Australia where there is very limited public participation in GMO regulation,[95] and legislative frameworks tend to focus on ‘just the science’ rather than purely ethical or cultural considerations.[96] Whilst bioethical issues also include concerns about biodiversity and environmental risks, biological warfare, religious restrictions, and eugenics – this essay will focus on two of the most common; animal welfare and GM/non-GM co-existence.

1 Animal welfare

Gene editing techniques can have irrefutable benefits for animal welfare, which is usually taken to include both physical health and behaviour.[97] For example, there are horn-less GE dairy cattle which are spared the painful horn removal procedures,[98] and GE chickens that do not pass on influenza virus to other poultry.[99] Relevantly to the latter, disease is a major problem in conventional breeding, leading to animal welfare problems and loss of life.[100] However, GE animals have can significant health problems of their own. These are most widely documented in GE animals with transgene expression of growth hormones, such as AA Salmon, and include lethargy, lameness, arthritis and increased susceptibility to stress; the latter of which was indicated by the death of several animals during or immediately after confinement in a restraint device.[101] Additionally, red GE animals producing pharmaceutical products in their milk have been observed to experience painful lactation.[102]

How these GE animal welfare issues will be dealt with is not yet clear. Australia lacks a consistent national law, with State and Territory governments left to legislate for animal production, welfare and enforcement.[103] For example, in NSW animal welfare is governed by the Prevention of Cruelty to Animals Act 1979 and accompanying regulations.[104] However, this is not designed to deal with situations where GE animals are in pain, or their welfare is otherwise compromised, by nothing more than their modified existence. For example, will owners of GE livestock fall under a legal obligation, where pain is being inflicted upon the animal, to take such reasonable steps as are necessary to alleviate the pain?[105] It is clear these legislative frameworks are not adequately equipped to deal with such scenarios. Instead, a sensible solution would be to mandate consideration of animal welfare, along with human health and the environment, in the risk-based assessment under the GT Act. Pursuant to the norms of bioethics discussed above, this would force scientists to develop GE animals unburdened by the range of health problems currently experienced.

2 Co-existence failures

Contamination of non-GMOs by their GMO counterparts is recognised as a global phenomenon.[106] Indeed, authors such as Cocklin et al. argue that even if segregation were possible, which field trials indicate is unlikely,[107] the costs of doing so would exceed the market price for maintaining the distinction.[108]

The law regarding liability and redress for GMO contamination events is piecemeal in Australia. Whilst some moratoria create compensatory mechanisms,[109] the GT Act neither creates liability, nor provides statutory immunity to common law avenues of redress.[110] The national framework therefore intends for liability to be determined by the courts pursuant to common law principles. In the case of Marsh v Baxter,[111] these questions were addressed in detail. On appeal, the WA Supreme Court held 2:1 that neither negligence nor nuisance could be made out against a farmer whose GM canola seeds had contaminated a neighbour’s farm, causing them to lose their organic certification. This decision – which largely came down to the plaintiff’s self-rendered vulnerability through the voluntary adoption of organic standards, as well as the benign nature of the contaminating GM canola swathes – has left farmers without effective common law remedies for contamination events.

Whilst it is acknowledged that contamination by GE plants would occur more frequently than GE animals, as the latter increase in market-penetration the law will nonetheless need to respond to this issue. There are several forms this response could take.

Firstly, as many academics suggest, the decision in Marsh v Baxter could be decided differently on different facts.[112] In particular, a duty of care may be established if the plaintiff’s vulnerability is not due to voluntary organic certification,[113] but an inability to sell products that must now be labelled ‘GE’. Nuisance may also be more readily established if the interference is not ‘benign’ readily-picked GM canola,[114] but cross-breeding with physically unhealthy livestock (as discussed above), or the economic harm from a successful patent infringement suit.

Secondly, the legislature may address the issue by introducing a statutory duty of care for GMO farming, which would have captured Baxter.

Thirdly, the legislature may address the issue through relevant regulatory frameworks. For instance, it may impose mandatory GM farmer insurance (for contamination claims) as a licence condition for authorisation under the GT Act.[115]

IV CONCLUSION

With the proliferation of gene editing technologies in the last decade, and an increasing demand for GMOs to address issues such as global food security, the future will likely entail an increasing market-penetration of green GE animals; the legal implications of which are relatively unknown. Part II identified that the overarching GT Act is suitably equipped to facilitate GE animals, despite some legal uncertainty around SDN-1 exemptions. Similarly, GE animals do constitute patentable subject matter, however the patent regime may not adequately address inadvertent patent infringement. Additionally, statutory licensing regimes may be required to ensure access to increasingly privatised genetic resources. Part III considered GE animals as ‘food’, identifying that green GE animals are likely to be regulated as such; rather than as a ‘drug’. Citing the outdated drafting of the Code regulating foods in Australia, Part III identified that several more recent GE animals would not be captured by the blanket prohibition and mandatory pre-market assessment of GMOs. On an identical basis, these same GE animals likely escape any mandatory labelling requirements, unless imposed as licence conditions under the GT Act. As FSANZ appears to be aware of these regulatory gaps, the author anticipates they will be addressed in the near future. Legal problems not so readily addressed however relate to animal welfare, and the State/Territory laws that are not equipped to deal with GE animals in pain due to their modified nature. In response, the author suggests mandating a consideration of animal welfare in the GT risk-assessment to transform scientists’ current norms. Additionally, the law remains unclear on issues of liability and redress due to co-existence contamination issues. However, the increasing market-penetration of GMOs will likely force the law to respond, in a number of possible ways, in order to provide legal certainty for Australian farmers. As such, it can be concluded that whilst regulatory frameworks are reasonably equipped to address GE animals as ‘technology’, they are currently inadequate to deal with GE animals as ‘food’. Furthermore, the increasing market-penetration of green GE animals raises significant bioethical challenges which the law, at this point in time, fails to adequately address. The author therefore proposes that a number of significant reforms are required before GE animals can be consistently, practically and effectively subsumed into our national diet.

V BIBLIOGRAPHY

A Articles/Books

Aliteri, Miguel and Peter Rosset, ‘Ten Reasons Why Biotechnology Will Not Ensure Food Security, Protect the Environment, or Reduce Poverty in the Developing World’ in J Morrey and R Sherlock (eds), Ethical Issues in Biotechnology (Rowman & Littlefield Publishers, 2002)

Amin, Latifah et al., ‘Determinants of Public Attitudes to Genetically Modified Salmon’ (2014) 9(1) PLoS One e86174

Amin, Latifah et al., ‘Risk perception towards food safety issues: GM foods versus non-GM food’ (2013) 11(1) Journal of Food, Agriculture & Environment 28

Bhunnoo, Riaz, ‘Food security and the Anthropocene’ (2017) 24(3) IPPR Progressive Review 210

Blakeney, Michael, ‘Organic versus GM Agriculture in the Courtroom in Australia and the United States’ (2016) 19(2) Journal of Agrobiotechnology Management & Economics 184

Bongoni, Radhika, ‘East versus West: acceptance of GM foods by European and Asian consumers’ (2015) 46(5) Nutrition & Food Science 628

Bray, Heather and Rachel Ankeny, ‘Not just about “the science”: science education and attitudes to genetically modified foods among women in Australia’ (2017) 36(1) New Genetics and Society 1

Bryant, John and Linda Velle, Introduction to Bioethics (John Wiley & Sons, 2nd ed, 2019)

Christiansen, Stine and Peter Sandøe, ‘Bioethics: limits to the interference with life’ (2000) 60 Animal Reproduction Science 15

Chu, Angus, et al., ‘Does intellectual monopoly stimulate or stifle innovation?’ (2012) 56(4) European Economic Review 727

Cocklin, Chris et al., ‘Competitiveness versus ‘clean and green’? The regulation and governance of GMOs in Australia and the UK’ (2008) 38 Geoforum 161

Carroll, Myles, ‘The new agrarian double movement: hegemony and resistance in the GMO food economy’ (2016) 23(1) Review of International Political Economy 1

Frewer, Lynn et al., ‘Genetically modified animals from life-science, socio-economic and ethical perspectives: examining issues in an EU policy context’ (2013) 30 New Biotechnology 447

Greger, Michael, ‘Trait selection and welfare of genetically engineered animals in agriculture’ (2010) 88 Journal of Animal Science 811

Heller, Michael and Rebecca Eisenberg, ‘Can Patents Deter Innovation? The Anticommons in Biomedical Research’ (1998) 280(5364) Science 698

Herrick, Clare, ‘’Cultures of GM’: discourses of risk and labelling of GMOs in the UL and EU’ (2005) 37(3) Area 286

Hindmarsh, Richard and Rosemary Du Plessis, ‘GMO regulation and civic participation at the “edge of the world”: the case of Australia and New Zealand’ (2008) 27(3) New Genetics and Society 181

Hino, Akihiro, ‘Safety Assessment and Public Concerns for Genetically Modified Food Products: The Japan Experience’ (2002) 30(1) Toxicologic Pathology 126

Huyghe, Christian, ‘Genetics and genetic modifications of plant architecture in grain legumes: a review’ (1998) 5(6) Agronomie 383

Idris, Siti et al., ‘Beyond Halal: Maqasid al-Shari’ah to Assess Bioethical Issues Arising from Genetically Modified Crops’ (2020) 26 Science and Engineering Ethics 1463

Jarosz, Lucy, ‘Comparing food security and food sovereignty discourses’ (2014) 4(2) Dialogues in Human Geography 168

Kolodinsky, Jane et al., ‘How consumers use mandatory genetic engineering (GE) labels: evidence from Vermont’ (2019) 36 Agriculture and Human Values 117

Lassen, Jesper, ‘Listened to, but not heard! The failure to represent the public in genetically modified food policies’ (2018) 27(8) Public Understanding of Science 923

Ludlow, Karinne, ‘Regulation of Genome Editing in Plant Biotechnology: Australia’ in H Dederer (ed), Regulation of Genome Editing in Plant Biotechnology (Springer Nature Switzerland) 63

Marques, Mathew et al., ‘Attitudes to genetically modified food over time: How trust in organizations and the media cycle predict support’ (2015) 24(5) Public Understanding of Science 601

Milligan, Ben and Michelle O’Keeffe, ‘Global Governance of Resources and Implications for Resource Efficiency in Europe’ (2019) 155 Ecological Economics 46

Neuhaus, Carolyn and Arthur Caplan, ‘Genome editing: Bioethics shows the way’ (2017) 15(3) PLoS Biology e2001934

Pariza, Michael, ‘A Scientific Perspective on Labeling Genetically Modified Food’ in P Weirich (ed), Labeling Genetically Modified Food: The Philosophical and Legal Debate (Oxford Scholarship Online)

Patel, Raj, ‘Stuffed and Starved: The Hidden Battle for the World Food System’ (Melville House Publishing, 2007)

Paull, John, ‘The failures of genetically modified organisms (GMOs): Resistance, regulation, and rejection’ (2019) 4(3) AGROFOR International Journal 139

Polcz, Sarah and Anna Lewis ‘A Menagerie of Moral Hazards: Regulating Genetically Modified Animals’ (2018) 46 The Jounral of Law, Medicine & Ethics 180

Rubel, Alan, ‘Genetically Engineered Animals and the Ethics of Food Labelling’ in P Weirich (ed), Labeling Genetically Modified Food: The Philosophical and Legal Debate (Oxford Scholarship Online)

Sanderson, Jay , ‘Who killed the EnviroPig? Assemblages, genetically engineered animals and patents’ (2015) 24(2) Griffith Law Review 244

Shear, Richard and Thomas Kelley, ‘A Researcher’s Guide to Patents’ (2003) 132(3) Plant Physiology 1127

Thygesen, Peter, ‘Clarifying the regulation of genome editing in Australia: situation for genetically modified organisms’ (2019) 28 Transgenic Research 151

Tsui, Annie Lin Jin, ‘Australian Regulation of Gene Technology: Impacts on Biodiversity’ 1(1) Macquarie Journal of International and Comparative Environmental Law 95

Vazquez-Salat, Nuria et al., ‘The current state of GMO governance: Are we ready for GM animals?’ (2012) 30 Biotechnology Advances 1336

Vecchione, Melissa et al., ‘Consumer knowledge and attitudes about genetically modified food products and labelling policy’ (2015) 66(3) International Journal of Food Sciences and Nutrition 329

Wickson, Fern, ‘From risk to uncertainty in the regulation of GMOs: social theory and Australian practice’ (2007) 26(3) New Genetics and Society 325

Zainol, Zinatul et al., ‘Mandatory labelling of genetically modified (GM) foods’ (2013) 15 International Environmental Agreements: Politics, Law and Economics 199

B Cases

Diamond v Chakrabarty [1980] USSC 119; 447 U.S. 303

Marsh v Baxter [2014] WASC 187

Marsh v Baxter [2015] WASCA 169

Organic Seed Growers and Trade Association et al. v. Monsanto Co 718 F.3d 1350 (Fed. Cir. 2013)

C Legislation

Australian New Zealand Food Standards Code – Standard 1.1.2 – Definitions used throughout the Code

Australian New Zealand Food Standards Code – Standard 1.5.2 – Food produced using gene technology

Australian New Zealand Food Standards Code – Schedule 26 – Food produced using gene technology

Food Act 2003 (NSW)

Gene Technology Act 2000 (Cth)

Gene Technology Regulations 2001 (Cth)

Patents Act 1990 (Cth)

Prevention of Cruelty to Animals Act 1979 (NSW)

Prevention of Cruelty to Animals Regulations 2012 (NSW)

D Reports

Australian Government Productivity Commission, Regulation of Australian Agriculture (Productivity Commission Inquiry Report, No. 79, 15 November 2016)

Food Standards Australia New Zealand, Final report: Review of food derived using new breeding techniques (Final Report, December 2019)

Office of the Gene Technology Regulator, Technical Review of the Gene Technology Regulations 2001: Decision Regulation Impact Statement (Report, 2018)

Senate Standing Committee on Science and the Environment, Parliament of Australia, Industrial Research and Development in Australia (Report, May 1979)

Standing Committee on Environment and Public Affairs, Parliament of Western Australia, Mechanisms for compensation for economic loss to farmers in Western Australia caused by contamination by genetically modified material (Report, No. 49, February 2019)

World Health Organisation Europe, The precautionary principle: protecting public health, the environment and the future of our children (Report, 2004)

E Internet Materials

‘Animal Welfare in Australia’, Australian Government, Department of Agriculture, Water and the Environment (Web Page, 2019) <https://www.agriculture.gov.au/animal/welfare/animal-welfare-in-australia#governments-responsibility>

‘AquaAdvantage Salmon’, U.S. Food & Drug Administration (Web Page, 2020) <https://www.fda.gov/animal-veterinary/animals-intentional-genomic-alterations/aquadvantage-salmon>

Christine Blank, ‘AquaBounty planning to label GM salmon in the US’, SeafoodSource (Article, 7 October 2019) <https://www.seafoodsource.com/news/supply-trade/aquabounty-planning-to-label-gm-salmon-in-the-us>

Fiona Breen, ‘Tasmania’s GMO ban good news for some, a ‘missed opportunity’ for others, ABC News (Article, 8 August 2019) <https://www.abc.net.au/news/rural/2019-08-08/tasmania-vows-to-keep-its-food-clean-and-green-and-gmo-free/11391852>

‘General information about GM foods’, Food Standards Australia New Zealand (Web Page, 2020) <https://www.foodstandards.gov.au/consumer/gmfood/gmoverview/Pages/default.aspx>

Paul Harris, ‘Monsanto sued small farmers to protect seed patents, report says’, The Guardian (Article, 13 February 2013) <https://www.theguardian.com/environment/2013/feb/12/monsanto-sues-farmers-seed-patents>

‘SDN: Site-Directed Nuclease technology’, NBT Platform (Factsheet, 2014) <https://www.nbtplatform.org/background-documents/factsheets/factsheet-site-directed-nucleases.pdf>

‘Topic: Food Security’, International Food Policy Research Institute (Web Page, 2020) <https://www.ifpri.org/topic/food-security>


[1] Chris Cocklin et al., ‘Competitiveness versus ‘clean and green’? The regulation and governance of GMOs in Australia and the UK’ (2008) 38 Geoforum 161.

[2] Peter Thygesen, ‘Clarifying the regulation of genome editing in Australia: situation for genetically modified organisms’ (2019) 28 Transgenic Research 151, 154.

[3] John Bryant and Linda Velle, Introduction to Bioethics (John Wiley & Sons, 2nd ed, 2019) ch 9, 196.

[4] Thygesen (n 2) 154.

[5] Nuria Vazquez-Salat et al., ‘The current state of GMO governance: Are we ready for GM animals?’ (2012) 30 Biotechnology Advances 1336, 1337.

[6] Michael Pariza, ‘A Scientific Perspective on Labeling Genetically Modified Food’ in P Weirich (ed), Labeling Genetically Modified Food: The Philosophical and Legal Debate (Oxford Scholarship Online) 2; Food Act 2003 (NSW) s 5.

[7] Pariza (n 6) 2.

[8] Latifah Amin et al., ‘Determinants of Public Attitudes to Genetically Modified Salmon’ (2014) 9(1) PLoS One e86174 2.

[9] Michael Greger, ‘Trait selection and welfare of genetically engineered animals in agriculture’ (2010) 88 Journal of Animal Science 811, 812.

[10] ‘AquaAdvantage Salmon’, U.S. Food & Drug Administration (Web Page, 2020) <https://www.fda.gov/animal-veterinary/animals-intentional-genomic-alterations/aquadvantage-salmon>.

[11] Ibid.

[12] Jay Sanderson, ‘Who killed the EnviroPig? Assemblages, genetically engineered animals and patents’ (2015) 24(2) Griffith Law Review 244, 245.

[13] Alan Rubel, ‘Genetically Engineered Animals and the Ethics of Food Labelling’ in P Weirich (ed), Labeling Genetically Modified Food: The Philosophical and Legal Debate (Oxford Scholarship Online) 21, 22.

[14] Ibid.

[15] Lynn Frewer et al., ‘Genetically modified animals from life-science, socio-economic and ethical perspectives: examining issues in an EU policy context’ (2013) 30 New Biotechnology 447, 452.

[16] Karinne Ludlow, ‘Regulation of Genome Editing in Plant Biotechnology: Australia’ in H Dederer (ed), Regulation of Genome Editing in Plant Biotechnology (Springer Nature Switzerland) 63, 102, 103.

[17] Mathew Marques et al., ‘Attitudes to genetically modified food over time: How trust in organizations and the media cycle predict support’ (2015) 24(5) Public Understanding of Science 601, 602.

[18] Pariza (n 6) 5.

[19] Christian Huyghe, ‘Genetics and genetic modifications of plant architecture in grain legumes: a review’ (1998) 5(6) Agronomie 383, 385.

[20] ‘Topic: Food Security’, International Food Policy Research Institute (Web Page, 2020) <https://www.ifpri.org/topic/food-security>.

[21] Riaz Bhunnoo, ‘Food security and the Anthropocene’ (2017) 24(3) IPPR Progressive Review 210, 211; Ben Milligan and Michelle O’Keeffe, ‘Global Governance of Resources and Implications for Resource Efficiency in Europe’ (2019) 155 Ecological Economics 46.

[22] Akihiro Hino, ‘Safety Assessment and Public Concerns for Genetically Modified Food Products: The Japan Experience’ (2002) 30(1) Toxicologic Pathology 126.

[23] Bhunnoo (n 21) 211.

[24] Marques (n 17) 614.

[25] Greger (n 9) 813.

[26] Miguel Aliteri and Peter Rosset, ‘Ten Reasons Why Biotechnology Will Not Ensure Food Security, Protect the Environment, or Reduce Poverty in the Developing World’ in J Morrey and R Sherlock (eds), Ethical Issues in Biotechnology (Rowman & Littlefield Publishers, 2002) 175, 176.

[27] Frewer (n 15) 455.

[28] Radhika Bongoni, ‘East versus West: acceptance of GM foods by European and Asian consumers’ (2015) 46(5) Nutrition & Food Science 628, 633.

[29] Lucy Jarosz, ‘Comparing food security and food sovereignty discourses’ (2014) 4(2) Dialogues in Human Geography 168, 171.

[30] Ludlow (n 16) 102; Frewer (n 15) 451; Marques (n 17).

[31] Cocklin (n 1) 165.

[32] Gene Technology Act 2000 (Cth) s 3.

[33] Ibid ss 10, 32; Thygesen (n 2) 152.

[34] See, for example: Ludlow (n 16) 72; Thygesen (n 2) 155; Fern Wickson, ‘From risk to uncertainty in the regulation of GMOs: social theory and Australian practice’ (2007) 26(3) New Genetics and Society 325, 336.

[35] Gene Technology Act 2000 (Cth) s 10.

[36] Gene Technology Regulations 2001 (Cth) sch 1; Office of the Gene Technology Regulator, Technical Review of the Gene Technology Regulations 2001: Decision Regulation Impact Statement (Report, 2018); ‘SDN: Site-Directed Nuclease technology’, NBT Platform (Factsheet, 2014) <https://www.nbtplatform.org/background-documents/factsheets/factsheet-site-directed-nucleases.pdf>.

[37] Gene Technology Act 2000 (Cth) s 32.

[38] As GE animals are unlikely to be assessed as posing minimal, low or negligible risk: Gene Technology Act 2000 (Cth) s 32.

[39] Gene Technology Act 2000 (Cth) pt 5.

[40] Latifah Amin et al., ‘Risk perception towards food safety issues: GM foods versus non-GM food’ (2013) 11(1) Journal of Food, Agriculture & Environment 28.

[41] Gene Technology Act 2000 (Cth) s 51(1).

[42] Ludlow (n 16) 82.

[43] World Health Organisation Europe, The precautionary principle: protecting public health, the environment and the future of our children (Report, 2004) 7.

[44] Zinatul Zainol et al., ‘Mandatory labelling of genetically modified (GM) foods’ (2013) 15 International Environmental Agreements: Politics, Law and Economics 199, 203.

[45] Annie Lin Jin Tsui, ‘Australian Regulation of Gene Technology: Impacts on Biodiversity’ 1(1) Macquarie Journal of International and Comparative Environmental Law 95, 97.

[46] Wickson (n 34) 333.

[47] Thygesen (n 2) 152.

[48] Gene Technology Act 2000 (Cth) s 62(1).

[49] Gene Technology Act 2000 (Cth) s 84.

[50] Ludlow (n 16) 68; Myles Carroll, ‘The new agrarian double movement: hegemony and resistance in the GMO food economy’ (2016) 23(1) Review of International Political Economy 1, 14.

[51] Ludlow (n 16) 68; Fiona Breen, ‘Tasmania’s GMO ban good news for some, a ‘missed opportunity’ for others, ABC News (Article, 8 August 2019) <https://www.abc.net.au/news/rural/2019-08-08/tasmania-vows-to-keep-its-food-clean-and-green-and-gmo-free/11391852>.

[52] Richard Shear and Thomas Kelley, ‘A Researcher’s Guide to Patents’ (2003) 132(3) Plant Physiology 1127, 1128.

[53] Senate Standing Committee on Science and the Environment, Parliament of Australia, Industrial Research and Development in Australia (Report, May 1979) 129.

[54] See, for example: Michael Heller and Rebecca Eisenberg, ‘Can Patents Deter Innovation? The Anticommons in Biomedical Research’ (1998) 280(5364) Science 698; Angus Chu et al., ‘Does intellectual monopoly stimulate or stifle innovation?’ (2012) 56(4) European Economic Review 727.

[55] Sanderson (n 12) 246.

[56] Patents Act 1990 (Cth) s 18(1)(a).

[57] Diamond v Chakrabarty [1980] USSC 119; 447 U.S. 303.

[58] Ibid 308.

[59] Patents Act 1990 (Cth) s 18(3).

[60] Ibid s 18.

[61] Siti Idris et al., ‘Beyond Halal: Maqasid al-Shari’ah to Assess Bioethical Issues Arising from Genetically Modified Crops’ (2020) 26 Science and Engineering Ethics 1463, 1472; Paul Harris, ‘Monsanto sued small farmers to protect seed patents, report says’, The Guardian (Article, 13 February 2013). <https://www.theguardian.com/environment/2013/feb/12/monsanto-sues-farmers-seed-patents>.

[62] Raj Patel, ‘Stuffed and Starved: The Hidden Battle for the World Food System’ (Melville House Publishing, 2007) 116.

[63] Organic Seed Growers and Trade Association et al. v. Monsanto Co 718 F.3d 1350 (Fed. Cir. 2013).

[64] Patents Act 1990 (Cth) s 123(1).

[65] Frewer (n 15) 449.

[66] Aliteri and Rosset (n 26) 176.

[67] Bryant and Velle (n 3) ch 10, 218.

[68] ‘General information about GM foods’, Food Standards Australia New Zealand (Web Page, 2020) <https://www.foodstandards.gov.au/consumer/gmfood/gmoverview/Pages/default.aspx>.

[69] Australian New Zealand Food Standards Code – Standard 1.1.2 – Definitions used throughout the Code s 2(2).

[70] Ibid s 2(3).

[71] Pariza (n 6) 2.

[72] Australian New Zealand Food Standards Code – Standard 1.5.2 – Food produced using gene technology s 3.

[73] Australian New Zealand Food Standards Code – Standard 1.1.2 – Definitions used throughout the Code, s 2(3).

[74] Food Standards Australia New Zealand, Final report: Review of food derived using new breeding techniques (Final Report, December 2019) 4.

[75] Ibid 9.

[76] Ibid 10.

[77] Ibid 5.

[78] Ludlow (n 16) 73.

[79] Australian New Zealand Food Standards Code – Schedule 26 – Food produced using gene technology s 3(4).

[80] Jane Kolodinsky et al., ‘How consumers use mandatory genetic engineering (GE) labels: evidence from Vermont’ (2019) 36 Agriculture and Human Values 117.

[81] Ibid.

[82] Pariza (n 6) 4.

[83] Zainol (n 44) 202; Melissa Vecchione et al., ‘Consumer knowledge and attitudes about genetically modified food products and labelling policy’ (2015) 66(3) International Journal of Food Sciences and Nutrition 329, 330.

[84] Australian Government Productivity Commission, Regulation of Australian Agriculture (Productivity Commission Inquiry Report, No. 79, 15 November 2016) 362.

[85] Ibid.

[86] Frewer (n 15) 455; see also the study by Amin et al. in a Malaysian cohort: Amin (n 40) 34.

[87] Rubel (n 13) 3, 4.

[88] Christine Blank, ‘AquaBounty planning to label GM salmon in the US’, SeafoodSource (Article, 7 October 2019) <https://www.seafoodsource.com/news/supply-trade/aquabounty-planning-to-label-gm-salmon-in-the-us>.

[89] Clare Herrick, ‘’Cultures of GM’: discourses of risk and labelling of GMOs in the UL and EU’ (2005) 37(3) Area 286, 289.

[90] Kolodinsky (n 80) 123.

[91] Australian New Zealand Food Standards Code – Standard 1.5.2 – Food produced using gene technology s 4.

[92] Ibid s 4(5).

[93] Gene Technology Act 2000 (Cth) s 62(1).

[94] Carolyn Neuhaus and Arthur Caplan, ‘Genome editing: Bioethics shows the way’ (2017) 15(3) PLoS Biology e2001934 5.

[95] Richard Hindmarsh and Rosemary Du Plessis, ‘GMO regulation and civic participation at the “edge of the world”: the case of Australia and New Zealand’ (2008) 27(3) New Genetics and Society 181, 195; Wickson (n 34) 334.

[96] Jesper Lassen, ‘Listened to, but not heard! The failure to represent the public in genetically modified food policies’ (2018) 27(8) Public Understanding of Science 923, 932; Ludlow (n 16) 68; Heather Bray and Rachel Ankeny, ‘Not just about “the science”: science education and attitudes to genetically modified foods among women in Australia’ (2017) 36(1) New Genetics and Society 1, 18.

[97] Stine Christiansen and Peter Sandøe, ‘Bioethics: limits to the interference with life’ (2000) 60 Animal Reproduction Science 15, 17.

[98] Sarah Polcz and Anna Lewis, ‘A Menagerie of Moral Hazards: Regulating Genetically Modified Animals’ (2018) 46 The Jounral of Law, Medicine & Ethics 180.

[99] Frewer (n 15) 449.

[100] Ibid.

[101] Greger (n 9) 1; Rubel (n 13) 13.

[102] Rubel (n 13) 13.

[103] ‘Animal Welfare in Australia’, Australian Government, Department of Agriculture, Water and the Environment (Web Page, 2019) <https://www.agriculture.gov.au/animal/welfare/animal-welfare-in-australia#governments-responsibility>.

[104] Prevention of Cruelty to Animals Regulations 2012.

[105] Prevention of Cruelty to Animals Act 1979 s 5(3)(b).

[106] John Paull, ‘The failures of genetically modified organisms (GMOs): Resistance, regulation, and rejection’ (2019) 4(3) AGROFOR International Journal 139, 143.

[107] Ibid 142.

[108] Cocklin (n 1) 171.

[109] Ludlow (n 16) 101.

[110] Ibid.

[111] Marsh v Baxter [2014] WASC 187; Marsh v Baxter [2015] WASCA 169.

[112] Ludlow (n 16) 102; Michael Blakeney, ‘Organic versus GM Agriculture in the Courtroom in Australia and the United States’ (2016) 19(2) Journal of Agrobiotechnology Management & Economics 184, 190; Paull (n 106) 145.

[113] Blakeney (n 112) 188.

[114] Ibid 190.

[115] GM farmer insurance was recommended, but not implemented, under the WA Parliamentary Inquiry following Marsh v Baxter: Standing Committee on Environment and Public Affairs, Parliament of Western Australia, Mechanisms for compensation for economic loss to farmers in Western Australia caused by contamination by genetically modified material (Report, No. 49, February 2019).


AustLII: Copyright Policy | Disclaimers | Privacy Policy | Feedback
URL: http://www.austlii.edu.au/au/journals/UNSWLawJlStuS/2021/4.html