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Deakin Law Review |
It is estimated that genetically modified (‘GM’) canola is worth $135 million a year to Australia’s canola harvest.[1] Yet the majority of Australian States[2] have recently acted to ban its release. As a result one of the largest agricultural companies undertaking GM research into canola in this country announced in May 2004 that it is ending its research here.[3] Regardless of whether that move is a positive or negative outcome for Australia, the laws that in part drove Monsanto Australia Ltd to withdraw are disappointing.
A national regulatory scheme was created in Australia in 2001 to regulate genetically modified organisms (‘GMOs’). The centerpiece of that scheme is the Gene Technology Act 2000 (Cth) (‘GT Act’). One significant advantage of that scheme was its uniform application throughout Australia. However, that scheme deals only with risks to the environment and the health and safety of people. It does not address other risks arising from GMO releases, including that of contamination of other organisms and land and the possible consequences of that contamination. The States have responded to those risks and in doing so have destroyed the uniformity of GMO regulation in Australia. Those responses are the subject of this article.
This article begins in Part II by briefly describing the technology involved in creating GMOs and why the fear of contamination arises. Part III outlines the long process of negotiation and consultation leading to the national regulatory scheme pursuant to which GMOs are developed and released in Australia. The relevant parts of the scheme for this article’s purposes are then outlined and analysed in Part IV. The tension between the Commonwealth and State Governments regarding gene technology (‘GT’) regulation, and the Policy Principle introduced in an attempt to diffuse it, are the subject of Part V. The State responses to that Principle are then examined in Part VI. Two tables summarising the consequences of the legislation are also provided. Conclusions are brought together in Part VII where it is submitted that if commercialisation of GMOs is to be encouraged in Australia, all risks posed by GMO releases should be considered under the national scheme. Given that this requires the States to surrender power to regulate in this regard this seems unlikely.
GM is the alteration of an organism’s genetic material. It often involves the directed rearrangement, insertion and/or deletion of particular parts, or gene sequences, of an organism’s genetic material.[4] Genetic material in most organisms is comprised of deoxyribonucleic acid (‘DNA’).[5] Since the DNA in every organism is made up of the same units, DNA from different sources can be combined.
One function of DNA is to provide the instructions needed for the organism’s cells to produce other molecules. Those molecules are in turn responsible for the total structure, function and growth of the cell and therefore ultimately many of the observable characteristics of the organism. If the DNA is altered, the molecules produced by the cell may also be altered. In some cases this results in changes to the characteristics of the organism. It is this ‘new’ organism or its products which will then be released into the environment. In the case of GM canola the change is resistance to a particular herbicide. GM carnations, also released in Australia, have been modified to change their flower colour. GM pigs, developed in Australia but never released, were modified to grow faster and produce leaner meat.
‘Contamination’ is ‘the unintentional and/or unwanted presence of a substance, organism or part of an organism in a particular environment, including within organisms. In the context of ... GMOs, contamination is the unintended/unwanted presence of a GMO, or the genetic material of a GMO or product of a GMO in an organism, environment or product.’[6]
There are two types of contamination – physical and genetic.[7] Physical contamination occurs where GMOs or their parts move from where they are released to other land.[8] For example, pollen or seed from GM plants may spread, or GM animals stray, onto neighbours’ land.[9] Once there the GMO may begin growing or feeding on that land. Physical contamination may also occur when a neighbour’s livestock or honeybees feed on GMOs that have spread from another’s land. Feeding on a GMO does not cause an animal to become GM itself.[10] However, it may cause the animal to lose, for example, organic certification.[11]
Genetic contamination is the contamination of the genetic makeup of other organisms. For example, cross-pollination may occur between a GMO and a third party’s organisms.[12] Genetic contamination is not a significant concern for all GMOs. Many crops are obligatory self-pollinators and no cross-pollination occurs.[13] Where crops are vegetatively produced or in other ways sexually sterile, gene transfer through cross-pollination is also impossible.[14] For example, cross-pollination is unlikely to occur in GM carnations.[15] The carnation is a domestic, cultivated species which produces little or no pollen. During commercial production of cut-flower crops, setting of seed does not occur.[16] Even for some sexually propagated crops the likelihood of cross-pollination is very small because of the physiological characteristics of the plant and crop-management, such as where a particular crop is surrounded by different crops.[17] There is also only a low risk of many GM animals contaminating another’s land or organisms because it is unlikely that animals that have been so carefully created would be kept in conditions from which they could easily escape.
Nevertheless some GMOs are considered to pose a high risk of contamination. For example, certain GM fish are reported to be high risk because of the likelihood of escape from containment. The widespread cultivation of some GM crops is also considered likely to have a major impact on existing forms of agriculture[18] and cross-pollination of neighbouring sexually compatible crops inevitable.[19] For example, there is considered to be a significant risk of contamination of land and organisms by GM canola. Australian research published in Science found pollen from a new canola plant[20] could travel up to three kilometres away, borne by wind and insects.[21] However, the amount of cross-pollination was minimal.[22]
Contamination may have a range of consequences for others. These include the loss of market advantage, the need to take precautionary measures,[23] need to comply with regulatory requirements,[24] possible infringement of patent rights[25] and general agricultural implications[26]. Particular concern has arisen with respect to the first of these. Neighbours may be non-GM farmers, growing conventional or organic organisms.[27] Contamination may cause them to lose any particular status or certification their organisms previously held.[28] Such loss could in turn cause the loss of some market advantage.[29] For example, the release may occur in an area where previously only organic produce was grown. By virtue of the GMO’s release, the organic certification of the area may be called into question.[30] Contamination may also mean the neighbour no longer satisfies contractual warranties provided by them regarding the GM status of their organisms.[31] Further, if the produce is to be exported, additional harm may be incurred. Even on the assumption that all GMOs grown in Australia have regulatory approval, not all will be of the same status with respect to overseas markets.[32] Some, for example, may not have been approved by overseas markets. The risk of contamination by such organisms with others that have been approved or are non-GM may mean the loss of overseas markets for the approved or non-GM organisms or delay in shipment whilst overseas regulators assess the significance of the contamination.[33]
Until recently there were no specific regulatory controls on the release of GMOs or their products into the environment. A voluntary and self-regulatory system had existed in Australia since the mid-seventies but there were no direct legal repercussions where those ‘regulations’ were not adhered to.[34] In October 1992 the Commonwealth Government announced, in its response to a report by the Commonwealth House of Representatives Standing Committee on Industry, Science and Technology,[35] that it would establish a statutory body to regulate GMOs.[36] The Commonwealth and State Governments began negotiations in 1993 to establish an authority.[37] Negotiations soon stalled.
In October 1997 the proposal for a national legislatively based regulatory system was revived and a Commonwealth-State Consultative Group on Gene Technology was formed.[38] That body prepared a paper, ‘Regulation of Gene Technology’, in November 1998 seeking views on the broad policy principles that might underpin the new scheme.[39] In May 1999 the Interim Office of the Gene Technology Regulator (‘IOGTR’) was established to oversee the development of the legislation to implement the national system and to work with GMAC.[40] The Consultative Group in collaboration with the IOGTR prepared a further discussion paper in October 1999.[41] Using the responses to that paper, the IOGTR drafted a Gene Technology Bill.[42]
The draft Bill[43] was released for public consultation in late December 1999.[44] Following a subsequent consultative process,[45] changes were made to the Bill before it was introduced into the House of Representatives on 22 June 2000.[46] Upon introduction to the Senate, the Bill was referred to the Senate Committee of Community Affairs which delivered its report, A Cautionary Tale: Fish Don’t Lay Tomatoes. A Report on the Gene Technology Bill 2000, on 1 November 2000.[47] Following further amendments in light of that report the Bill was enacted and took effect as the GT Act on 21 June 2001.[48]
A preliminary issue when the regulatory scheme was being created was whether to have central Commonwealth control or state based control. It was generally agreed that it was better to have a centrally controlled scheme rather than eight potentially different State based schemes together with a Commonwealth scheme. However, the Commonwealth does not have the constitutional power to regulate all dealings with GT. Therefore for a national system to operate, it was essential that there be complementary Commonwealth and State legislation. This is what has been done.
Implementation of the new system occurred through two parts. The first was a national cooperative scheme of Commonwealth and State legislation, such legislation being essentially the same.[49] The second was an inter-governmental agreement, called the Gene Technology Agreement (‘GT Agreement’), to which the Commonwealth and States are all party. These two parts are described in more detail below.
Each State must effectively adopt the GT Act into its own law for the national scheme to apply. By virtue of the State Acts the national regulator, the Gene Technology Regulator (‘GTR’), established under the Commonwealth Act is recognised and granted power to act in each State. All jurisdictions except WA[50] and the NT have introduced the necessary complementary legislation.[51] Five States have also introduced accompanying Regulations.[52]
Pursuant to the GT Agreement, the States need not adopt identical legislation and may choose not to adopt particular sections of the Commonwealth Act.[53] For example, the NSW legislation[54] prohibits the licensing of actions prohibited by a moratorium order made under other NSW legislation.[55]
The GT Agreement took effect from 11 September 2001.[56] It sets out the understandings between the participating Governments. The roles and responsibilities of each of the Governments in the administration and enforcement of the scheme are also described.[57] Further, the Agreement provides for the review of the implementation and effectiveness of the national scheme as soon as possible after four years operation of the GT Act. Finally, it establishes the Gene Technology Ministerial Council (‘GTMC’).[58] As discussed below, the actions of this Council were a necessary step in the introduction of the State legislation considered in this article.
The GT Act is the primary legislation regulating GMOs in Australia. The object of the 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 GT, and by managing those risks through regulating certain dealings with GMOs’.[59] The discussion below refers to the Commonwealth Act. As discussed above, adopting State legislation should largely mirror the provisions of the Commonwealth legislation and therefore essentially be the same.
All ‘dealings’[60] with GMOs in Australia are prohibited unless they are authorised under the GT Act.[61] However, inadvertent use of GMOs is not an offence under the legislation.[62] For example, where the user did not know that their organism is, or had been contaminated by, a GMO there will be no offence. Further, the GTR’s enforcement powers do not apply to such people.[63]
A GMO [64] is defined as:
(a) | an organism that has been modified by GT; or |
(b) | an organism that has inherited particular traits from an organism (the initial organism), being traits that occurred in the initial organism because of GT; or |
(c) | anything declared by the regulations to be a genetically modified organism, or that belongs to a class of things declared by the regulations to be genetically modified organisms; |
but does not include:
(d) | a human being, if the human being is covered by paragraph (a) only because the human being has undergone somatic cell gene therapy; or |
(e) | an organism declared by the regulations not to be a genetically modified organism, or that belongs to a class of organisms declared by the regulations not to be genetically modified organisms. |
‘Organism’ is defined as:
any biological entity that is:
(a) | viable; or |
(b) capable of reproduction; or
(c) capable of transferring genetic material.[65]
‘Gene technology’ for the purposes of the legislation means:
any technique for the modification of genes or other genetic material, but does not include:
(a) | sexual reproduction; or |
(b) | homologous recombination; or |
(c) | any other technique specified in the regulations for the purposes of this paragraph.[66] |
Although the definitions are broad, they were not intended to regulate every organism that has had its genetic material altered. Many ‘altered’ organisms are not caught by the definitions. The GT Act therefore does not regulate any dealings with such organisms. Organisms not regulated include those described in paragraphs (d) and (e) of the definition of GMO. Paragraph (d) refers to human beings who have undergone some types of gene therapy and is not relevant to this article. Paragraph (e) reflects the capacity for the Regulations to declare that certain organisms or classes of organisms are not GMOs.[67] This allows those organisms that were not considered to be GMOs prior to the creation of the scheme to continue to be treated as non-GMOs under the new scheme.[68] Such organisms generally are those that can occur in nature and/or commonly used in biological research and/or have a very long history of usage in Australia and overseas.[69] For example, plants formed by protoplast fusion,[70] a standard technique used for many years by plant breeders, are not GMOs for the purposes of the Act.[71]
Other organisms not regulated by the legislation are those not produced by GT as defined above. The definition of ‘gene technology’ provides that techniques may be specified in the Regulations as not being GT. The Regulations provide that somatic cell transfer[72] is not GT if the transfer does not involve GM material. Accordingly many types of cloning are not included.[73] This is because cloning does not require the modification of genes or other genetic material but instead involves the replication or duplication of existing genetic material.[74]
It is only ‘dealings’ with GMOs that are regulated. ‘Deal with’ in relation to a GMO for the purposes of the Act means:
(a) | conduct experiments with the GMO; |
(b) | make, develop, produce or manufacture the GMO; |
(c) | breed the GMO; |
(d) | propagate the GMO; |
(e) | use the GMO in the course of manufacture of a thing that is not the GMO; |
(f) | grow, raise or culture the GMO; |
(g) | import the GMO; |
and includes the possession, supply, use, transport or disposal of the GMO for the purposes of, or in the course of, a dealing mentioned in any of paragraphs (a) to (g).[75]
Most uses, whether a commercial application or use by a consumer, are dealings with a GMO for the purposes of the legislation. For example, although displaying a GM carnation in a vase at home would not be a ‘dealing’ pursuant to the Act, trying to propagate the carnation in the backyard would be. The raising of GM pigs and use of their meat in the manufacture of any other product, such as quiche, are also dealings for these purposes. Importantly for this article, releasing GMOs into the environment is a dealing pursuant to the Act.
The national scheme is administered by the GTR.[76] The GTR heads the national Office of the Gene Technology Regulator.[77] She[78] is not subject to direction from anyone in the performance or exercise of her functions or powers, subject to the limitations provided for in the Act.[79] The Regulator has power to do all that is necessary or convenient to perform her functions.[80] One of the Regulator’s key functions is to authorise dealings with GMOs.
Four categories of dealings are exempted from the general prohibition on dealings with GMOs. Such dealings are authorised provided certain conditions and requirements are met. These categories are:
(a) Exempt dealings;
(b) Notifiable low risk dealings;
(c) Dealings listed on the GMO Register; and
(d) Licensed dealings.
Only the later two categories can involve releases of GMOs into the environment. As yet, no GMO has been approved for inclusion on the GMO Register.[81] This article therefore focuses on the last category, licensed dealings.
When the GTR receives a licence application, an initial screening of the application for completeness is carried out. This includes checking that all required information is included[82] and that the application is not inconsistent with any policy principles issued by the GTMC such as the Designated Areas Policy Principle discussed below.[83] The applicant must also be a suitable person.[84] Suitability depends, in part, on whether the applicant has any ‘relevant convictions’.[85] A relevant conviction is a conviction for an offence under a law relating to the health and safety of people or the environment.[86]
If the application and applicant are satisfactory, the GTR must then assess the application. The GTR can, at any time, request further information from a licence applicant in order to assist in decision making and can refuse to consider an application if this is not complied with.[87]
Two types of licences may be issued by the GTR.
• | Licences for dealings that do not involve the intentional release of a GMO into the environment (a DNIR licence); and |
• | Licences for dealings that do involve the intentional release of a GMO into the environment (a DIR licence). |
The application must specify whether any of the proposed dealings involve the intentional release of a GMO into the environment.[88] This determines the next steps that must be taken by the GTR. There are separate assessment processes for each of the two types of licence application.[89] A more rigorous process is required where there is to be an intentional release of a GMO into the environment. No distinction is made in the legislation on the basis of why the release is being made.[90] For example, whether the release is to be made as part of a field trial or for commercial release purposes.
An ‘intentional release of a GMO into the environment’ is defined in the Act as meaning a dealing where:
the GMO is intentionally released into the open environment, whether or not it is released with provision for limiting the dissemination or persistence of the GMO or its genetic material in the environment.[91]
‘Environment’ is defined in the Act as including ‘the qualities and characteristics of
locations, places and areas’.[92]
After following the relevant procedures, the GTR must decide whether to grant the licence and, if so, on what conditions.[93] The GTR is prohibited from issuing any licence unless she is satisfied that any risks posed by the proposed dealings can be managed in a way that protects public health and safety and the environment.[94] The regulatory regime created by the GT Act therefore accepts that there are risks in allowing GMO releases. It proceeds on the basis that if those risks can be managed the release may occur subject to conditions thought necessary to address that risk. Where the Regulator considers that there is an unacceptable risk in a GMO release, approval to release may be refused or licence conditions may be imposed to limit such risk to an acceptable level. The imposition of such conditions does not, though, eliminate the potential for escape.
For risk assessment, risks posed by GMOs are considered ‘in the context of the risks posed by the non-modified parental organisms in the receiving environment’.[95] For example, in the case of canola, risk was judged by considering the adverse effects that may arise from the new characteristics of the GM canola caused by the modification which are different to those effects threatened by non-GM canola.[96] The potential hazards to the environment which were considered as part of the assessment of GM canola included whether the new genes in the GM canola might transfer to non-GM canola crops or other organisms with any adverse consequences for the environment.[97] The GTR concluded that there would be some contamination of non-GM canola.[98] Nevertheless she decided that the ‘risks’ posed by the proposed commercial release of the GM canola were no greater than those posed by conventional (non-GM) canola because conventional canola also contaminates other crops.[99] It seems, therefore, that they were ‘acceptable’ risks.
The GTR considers that she is limited in the risks that she can consider and attempt to control.[100] She does not evaluate economic and social considerations, such as risks to trade and marketing and the effect of GMOs on other forms of agriculture. For example, when releasing the draft risk assessment and risk management plan (‘RARMP’) for the commercial release of one GM canola, the Regulator made the following comments:[101]
There has been considerable media and written communications about the possible impact of the uptake of GM canola on non-GM crops and markets. Evaluation of trade, marketing and cost-benefit issues has been intentionally excluded from the Gene Technology Act 2000 assessment process. ... Therefore, this RARMP focuses on the protection of human health and safety and the environment, and does not draw any conclusions about the possible costs or benefits of GM canola to farmers or the agricultural industry.
The impact of contamination of non-GM agricultural crops or animals is classified by the GTR as economic considerations, not within the scope of her assessment. The attitudes of particular localities and States to the release of any particular GMO in their jurisdiction are also not grounds for refusal of a licence. For example, in 2002 the GTR received a licence application for the release of a GM canola.[102] The release was to occur in ‘all canola growing areas of Australia’.[103] Licence was therefore being sought to release in some areas where the State Government or individuals opposed the release.[104] The licence was granted on 25 July 2003.[105] At that time, the release of GM canola was prohibited by legislation in Tasmania and NSW.[106] This is not noted in the GTR’s licence conditions. Such licensing was not contrary to the GT Act but demonstrates the irrelevance of socio-economic implications of GMO releases to GTR decisions.
There is considerable uncertainty as to the scope of the risk assessment required under the Act and when there is an unacceptable risk justifying refusal of a licence. Nevertheless, it will be submitted that a licence could be refused on the basis of considerations additional to those currently considered by the GTR, including some socio-economic considerations.
Uncertainty arises first, as Lawson has pointed out, because the GTR does not acknowledge inherent value judgments in making decisions.[107] The GTR claims there is no balancing of risk and benefit by her.[108] Yet the terminology used by the GTR often refers to whether the level of risk is ‘acceptable’ but does not clarify how acceptability is to be judged.[109] There is no explanation, as Lawson says, of ‘why a particular risk is worth taking’.[110]
Secondly, the width of the basis for licence refusal is unclear. The Act does not provide that a licence can be refused only if one or both of the health and safety of people or the environment cannot be protected.[111] It provides that where risks to those two things cannot be satisfactorily managed a licence must be refused.[112] Arguably a licence could be refused on other grounds. However, it is unlikely that a court would agree with such an argument in light of the object of the Act.[113]
Finally, and most importantly, it is uncertain what risks are relevant in a risk assessment. It is submitted that some economic and social consequences of GMO releases may justify refusal of a licence, within the object of the Act. This submission is made on two grounds.
First, the Act requires that RARMPs be considered by the GTR when licensing decisions are made.[114] It is submitted that any risk, including risk to other forms of agriculture, can and should, be considered by the GTR when preparing RARMPs. The Act provides that the risks posed by proposed dealings ‘including any risks to the health and safety of people or risks to the environment’ must be taken into account in preparing a risk assessment.[115] The inclusive phrasing of this section indicates that risks other than those to people or the environment are relevant. This is supported by the wording of the section concerning circumstances when a licence must be refused. It says that if the health and safety of people and the environment cannot be protected by the management of ‘any risk posed by the dealings proposed to be authorised’ then the licence must be refused.[116]
No further guidance on what risks are to be considered is given in the Act or the Regulations. For example, there is no explanation as to whether the Regulator must take into account the effect of a release on neighbouring non-GM crops.[117] Due to the lack of guidance in the statute, the GTR released the Risk Analysis Framework for Licence Applications.[118] Importantly, it defines ‘risk management’ as incorporating ‘scientific, technological, social and economic information and community values’.[119] ‘Risk’ is also defined broadly as ‘[t]he probability that, in a certain time frame, an adverse outcome will occur in a person, group of people, plants, animals and/or the ecology of a specified area that is exposed to a GMO’.[120] The Framework also refers to the GTR addressing ‘the impact of GMOs on agroecosystems and the measures necessary to manage the risks’.[121] However, the Framework is a guide only and is not mandatory or enforceable.[122]
The Explanatory Memorandum accompanying the GT Act identified the risk to Australia’s capacity to maintain diverse farming practices because of the impact of contamination on traditional or organic crops as one that caused concern to the community.[123] However, that risk is not explicitly referred to in the Act, Regulations or Framework.[124] Nor does the Framework expressly refer to possible effects on neighbouring non-GM farmers.[125] The Framework does note, though, that it is not a comprehensive list of every possible risk that could be considered by the Regulator.[126]
Secondly, it is asserted that the effect and implications of GM crops on non-GM crops is an environmental concern pursuant to the GT Act’s definition of environment.[127] ‘Environment’ as noted above is defined as including ‘the qualities and characteristics of locations, places and areas’.[128] It is submitted that, as McGrath asserts, ‘environment’ for the purposes of the GT Act arguably includes non-GM crops in the area of release. Further, as McGrath has concluded, by failing to ‘view the issue of non-GM crops and areas where they are grown as part of the environment and take those into account’ there has been a failure to carry out the object of the Act.[129] These submissions are made on the following three grounds.
First, amongst the matters the GTR must consider when preparing the risk assessment for DIR applications are the matters listed in paragraphs 49(2)(a) to (f).[130] Two of these are ‘provisions for limiting the dissemination or persistence of the GMO or its genetic material in the environment’[131] and ‘the potential for spread or persistence of the GMO or its genetic material in the environment’.[132] Matters prescribed by the Regulations must also be taken into account.[133] Regulation 10 provides that, inter alia, the potential of the relevant GMO to be harmful to other organisms, adversely affect any ecosystems, transfer genetic material to another organism or spread or persist in the environment must all be taken into account.[134] Arguably all of these matters are particularly relevant if environment is given the broad interpretation suggested and may support a wide interpretation. However, they are also relevant even if the GTR’s narrow understanding of environment as not including such matters is used. Therefore their inclusion is not particularly helpful.
Secondly, during the Bill’s passage through the Senate, attempts to include measures dealing with ecologically sustainable development were rejected.[135] The reason given was that the Senate did ‘not consider a separate definition [of ecological sustainability] is required, because ecological sustainability is not separate and distinct from the environment’.[136] The Senate therefore considered environment to include ecological sustainability considerations. Non-GM crops, as part of the ecosystem, should therefore be protected.[137]
Finally the conditions that are or can be imposed on licences include conditions that, whilst minimising risks to the environment in a narrow sense, also minimise risk to other farmers and forms of agriculture. For example, buffer zones can be required around a GM crop. A Commonwealth Parliamentary Committee in its report concerning, in part, GM contamination described the steps government could take or was taking to limit contamination of non-GM crops. It listed the GTR setting conditions to prevent contamination and policing compliance as one measure that could be taken.[138] The Committee therefore arguably interpreted the then to be enacted legislation as capable of reacting to such risks.
During the negotiations leading to the GT Act, Tasmania in particular, wanted to reserve the power to withdraw from the national scheme in order to prevent GMO releases within its boundaries and to establish itself as a GM-free area. Nevertheless, the GT Act, in the end, did not include an opt-out clause.
Where the GTR has approved a release, she will have considered the protection of human health and safety and the environment with advice from all jurisdictions and expert bodies. Accordingly, States which do not want the GMO released in their jurisdiction cannot refuse release on those grounds. Nevertheless, the States have concerns about, inter alia, the impact of GMO releases and GM contamination on local trade and export markets and the liability of those inadvertently contaminated by GMOs. Accordingly, some States wanted to maintain a residual capacity to refuse to allow GMO releases within their jurisdiction on the basis of such considerations.[139] It was agreed that the States should have the option of declaring part or all of their jurisdiction GM-free. GM-free areas prevent such concerns becoming reality, at least while the issues are further explored by the States.
For this option to be available to States, the GTMC needed to create a Policy Principle. As noted above, the GTMC oversees the operation of the national scheme. It comprises one Minister from the Commonwealth and each State.[140] The Council provides broad policy guidance to the GTR.[141] That guidance can be in various forms, one of which is policy principles.[142] Policy principles are mandatory. The GTR cannot issue a licence if to do so would be inconsistent with a policy principle.[143] The Council has issued one policy principle thus far.
On 31 July 2003 the Council issued the Gene Technology (Recognition of Designated Areas) Principle 2003 (the ‘Designated Areas Policy Principle’).[144] The Principle took effect from 5 September 2003.[145] The Principle was issued ‘for the purposes of recognising areas (if any) designated under a State law for the purpose of preserving the identity of GM crops, non-GM crops, or both GM crops and non-GM crops, for marketing purposes’.[146] The Principle is relevant only to licence applications where it is intended that the GMO will be released into the environment.[147] It is not intended to either endorse or oppose the principle of designating GM or non-GM areas.[148] Nor is it intended to otherwise affect the GTR’s discretion in licensing decisions or role of assessing and managing risks to the health and safety of people or the environment.[149] Finally, it is also not intended that the State laws, if any, be duplicated in any licence conditions imposed by the GTR.[150]
The Policy Principle refers only to GM or non-GM crops. The section of the GT Act empowering the Council to make such principles limits the Council’s power in that way.[151] The Regulatory Impact Statement on the Principle states that ‘crop can be interpreted broadly and in this Regulatory Impact Statement it has been considered in this broad sense to cover all farmed GMOs, both terrestrial and aquatic.’[152] Accordingly, both GM plants and animals will be affected by the Principle’s introduction. The Principle and the empowering section also refer to ‘marketing purposes’. The Regulatory Impact Statement states that this has been taken broadly to mean impacts on the marketability of a specific product or its entrance into the marketplace although it may be interpreted in different ways by the States.[153]
The Designated Areas Policy Principle was not intended to compel any State to make laws designating an area for the purpose of identity preservation.[154] Each jurisdiction needed to decide whether such action was desirable in light of commercial, rather than safety or environmental, risks.[155] The proposed general commercial release of GM canola in 2003 lead many States to consider imposing moratoriums on GMO releases.[156] As at 12 May 2004 all States but Queensland[157] and NT[158] had declared moratoria on the commercial release of certain GMOs.
Generally, the legislation in each jurisdiction provides that a moratorium order may be made by the responsible Minister[159] that designates all or part of the State to be GM-free.[160] Exemptions or permits are then provided for.[161] The legislation creates considerable uncertainty for those wanting to release GMOs. In no jurisdiction is there a framework against which it can be confidently judged whether a declaration or exemption will be made or revoked.[162] Only SA provides for consultation before an order is made.[163] In NSW and SA consultation is required before making an exemption.[164] Further, although all the legislation is purported to be for the purpose of market protection, only the new Tasmanian Bill explicitly requires consideration of the impact of GMOs on non-GM agriculture when making decisions and even then it is only with respect to permits.[165]
The legislation also differs in application because of the differing definitions used. For example, the moratorium applies to only prescribed GM plants and their products under the current Tasmanian Act, all GMOs under a proposed Tasmanian Bill, GM plants in Victoria and WA, both GM food plants and animal feed plants in WA and only GM food plants in ACT and NSW.[166] The threshold for GM presence is addressed only in the SA and Victorian legislation.[167] The lack of a clear threshold as to when the presence of a GMO in a crop can be disregarded creates considerable uncertainty in determining when the legislation applies.
The offences created by, and defences provided in, the legislation also differ between States. For example, in SA and Tasmania, neither intention nor recklessness is required to contravene the legislation.[168] In ACT the recklessness must be not only as to the GM status of the organism but also as to whether there is a contravention of the moratorium.[169] In WA the moratorium does not apply to GTR licensed field trials[170] or cultivation not involving intentional release into the environment.[171] Whilst in Victoria, there is an automatic exemption for the cultivation of GMOs in accordance with a DNIR license from the GTR.[172]
There is similar disparity with respect to the treatment of those whose organisms are inadvertently contaminated. As under the GT Act, in all jurisdictions such people are unlikely to be convicted of contravening the moratorium, either because they will not have the requisite intention or because a defence will apply. Nevertheless in all States the contaminated crops can be destroyed or ordered to be destroyed.[173] In Victoria though this can only be done with the order of the court.[174] In ACT and NSW the person can also be ordered not to make certain future uses of their property.[175] In ACT, NSW, Victoria and Tasmania (under its current regime) no compensation is available under the legislation to such persons for these losses.[176] Additionally, in NSW and under the proposed Tasmanian Bill the owner or person with custody or control of the contaminated plants is liable for the costs of destruction.[177] However, in SA, Tasmania and WA compensation is available from the Government to such person for loss or damage because of actions under the Act.[178] In SA and WA the ‘releasor’ can then be ordered to repay the Government such compensation or to compensate the inadvertently contaminated person directly.[179]
Finally, none of the legislation protects GMO ‘releasors’ who comply with the legislation from common law or other statutory liability. Interestingly, although the penalties for offences under the State legislation are serious,[180] an offence under the moratoriums may not be relevant to whether a licence applicant is a suitable person under the GT Act. As noted above, only convictions under legislation for the protection of the environment or the health and safety of people are described as ‘relevant’ to the GT Act licence procedure.[181] In each case, the purpose of the State legislation discussed below is to preserve the identity of GMOs and/or non-GMOs for marketing purposes, rather than protect people or the environment.[182] The exception to this may be Tasmania where the current relevant Act may be considered one for the protection of the environment.[183] However, if the new Tasmanian Bill discussed below is enacted, this will not be the case.[184]
The responses of each State, other than Queensland and NT, to the release of GMOs in their jurisdiction are described below. A table summarising the most significant aspects of each State’s legislative response to GMO releases is then provided. A second table summarises the legality of releases of example GMOs under State legislation. A critique of the legislation is made in the last section of this Part.
The ACT Government announced on 17 June 2003 that it would introduce a three year moratorium on the commercial release of GMOs.[185] On 11 December 2003 the Government tabled a draft Bill. That Bill, the Gene Technology (GM Crop Moratorium) Bill 2004, seeks to prohibit the commercial production of certain GMOs in the ACT. The Bill is generally the same as the NSW legislation although there are some differences.
The Minister may make a moratorium order prohibiting the cultivation[186] of stated GM food plants[187] in the ACT.[188] Food plants are plants grown primarily for, or as an ingredient of, food for human consumption.[189] This would not include plants grown as livestock feed, even if the livestock are to be used as human food. Exemptions can be granted.[190] However, unlike in NSW the Minister need not consult prior to making an exemption. The legislation expires on 17 June 2006.[191]
It will be an offence to cultivate a GM food plant in contravention of a moratorium order if the person is reckless about whether the plant is a GM food plant and whether the cultivation is in contravention of an order.[192] This is different to NSW where the required intent is knowledge or recklessness and it is not necessary there be such intent with respect to whether or not there is any contravention of a moratorium order. Anyone, whether inadvertently contaminated or otherwise, can be directed to, inter alia, destroy a plant that contravenes the legislation.[193] Additionally, future use of the contaminated land can be restricted.[194] Unlike in NSW though, compensation from the Government is available in limited circumstances.[195] However, this requires that an inspector have destroyed the plants. This will occur only if the person has first failed to comply with a destruction direction.[196] Such failure is an offence.[197]
A private member’s bill prohibiting the release of all GMOs[198] into the environment was tabled in the Legislative Assembly on 26 November 2003.[199] Pursuant to the Bill, the GMO (Environment Protection) Bill 2003 (ACT), the entire ACT is designated as an area for the purpose of preserving the identity of non-GM crops for marketing purposes.[200] It will be an offence to knowingly deal with a GMO, if it is intended, or the person is reckless or negligent, that the dealing result in the GMO’s release into the environment.[201] No exemptions or licences are provided for. Nor is there provision for compensation to anyone affected by a breach of the legislation or authorised GMO release. While there are considerable monitoring powers[202] and provision is made for compensation to be paid by the Territory in some circumstances[203] there is no power to order the destruction of contaminated organisms.
During the 2003 NSW State Election, the Labor government included a policy for a three year moratorium on the introduction of new GM food crops in NSW.[204] That policy became law pursuant to the Gene Technology (GM Crop Moratorium) Act 2003 (NSW). Under that Act the relevant Minister can publish a moratorium order prohibiting the cultivation[205] of GM food plants.[206] Food plants are defined in the same way as in ACT.[207] A moratorium order with respect to the GM canola was published on 25 July 2003.[208] There is no minimum or maximum time limit for such an order although the Act expires in 2006.[209]
It is an offence to cultivate a GM food plant contrary to the moratorium knowing or being reckless as to whether the plant is a GM food plant.[210] Exemptions can be granted.[211] For example, dealings with GM canola not involving intentional release into the environment are exempted from the moratorium.[212] A new body, the NSW Agricultural Advisory Council on Gene Technology, must be consulted before an exemption is made.[213] No provision is made for compensation to any third person affected by a breach of the legislation. Nor is a person whose crop is destroyed or otherwise affected[214] after being contaminated entitled to compensation under the Act.[215] This includes where future cultivation of the contaminated land is prohibited.[216]
The Genetically Modified Crops Management Act 2004 (SA) commenced on 29 April 2004.[217] It provides for the designation of areas of the State (including the whole State[218]) as GM or GM-free for all or particular crops to preserve the identity of food crops.[219] The Act applies only to GM food crops.[220] ‘Food crops’ include crops intended for livestock consumption as well as human consumption.[221] Animals are not included in the term ‘crop’.
Under the Act, cultivating a GM food crop in a designated area[222] is an offence.[223] Exemptions can be granted for experimental, limited or small scale cultivation.[224] There is no requirement that the cultivation be done knowingly or recklessly as to whether the crop is GM. However, the Act provides for a defence for those innocently contaminated by a GMO. Such people are protected from any action in a SA court or under SA law on account of the fact that the material is present on their land or that the person has dealt with the material.[225] The defence requires the owner or occupier of the contaminated land not to have ‘deliberately dealt with a crop knowing that genetically modified plant material was present in order to gain a commercial benefit’.[226] The court must also be satisfied that it is not in the interests of justice that another person’s rights with respect to the material should be recognised or protected.[227] This defence would seem to protect inadvertently contaminated farmers from conviction for offences under the GT Act 2001 (SA), other SA environmental legislation or from common law liability.
GM crops cultivated in contravention of the Act, whether an offence or not, can be destroyed.[228] Even those inadvertently contaminated may have their crops destroyed. In such cases, compensation is payable by the Crown.[229] Contraveners of the Act can be required to reimburse the Government for destruction costs.[230] Furthermore, convicted offenders can be ordered, inter alia, to compensate others for loss or damage caused by any contravention of the legislation or pass on any financial benefit from the offence to the Government.[231] Unlike in ACT and NSW though, there is no power to restrict the future use of land. The Act is to be reviewed by 29 April 2007.[232]
A further Bill dealing with GMOs has also been introduced into the South Australian Parliament. That Bill is the Gene Technology (Responsibility for the Spread of Genetically Modified Plant Material) Bill 2003.[233] Pursuant to it those with a proprietary interest in a GM plant will be liable in tort to owners or occupiers of land who suffer loss or damage because the GMO has spread to it.[234] It is not necessary that the defendant has been negligent.[235] There is one defence. It requires the defendant to prove, amongst other things, that they had produced[236] ‘comprehensive instructions of the highest standard relating to the measures’ to prevent the spread of the material.[237] The defence is available only if the defendant proves that they took all reasonable steps to ensure the instructions were always issued with the supply of the plant material but the instructions had not been complied with to a material degree.[238] There is no explanation of how a court is to determine whether the instructions are of the ‘highest standard’ or what factors are relevant in making that determination. It is not clear therefore whether meeting the requirements under the GT Act and/or standards set by the industry concerned would be sufficient.
Tasmania had acted to limit GMO releases in that jurisdiction before the introduction of the Policy Principle.[239] The possession[240] of certain GM plants and plant materials has been banned in Tasmania since 22 July 2000[241] to protect Tasmania’s marketing image.[242] Under current arrangements, all GMOs are declared pests under the Plant Quarantine Act 1997 (Tas).[243] All of Tasmania[244] has been declared a protected area.[245] Certain GM plants and their products are then prohibited from being moved into the State for intentional release into the open environment.[246] Contravention of the prohibition is an offence, punishable by fine.[247] The legislation provides for a defence if the ‘offender’ proves that the offence was not the result of any failure to take all reasonable action and care to avoid committing the offence.[248] The plants can be destroyed under the Act, whether the owner has been inadvertently contaminated or not.[249] The owner/occupier is then liable for the costs of destruction.[250] No compensation from the Government is available.[251] Banned plants include GM canola but not non-food plants such as GM carnations.[252] Permits are provided for under the legislation.[253] The ban is to be reviewed by 30 June 2008.[254] There is also an extra-legislative moratorium on the commercial release of GM animals in Tasmania and the Government is opposed to the use of GM livestock feed.[255]
On 7 April 2004 a new Bill was introduced to the House of Assembly.[256] That Bill, the Genetically Modified Organisms Control Bill 2004, applies to GM plants and animals.[257] Under the Bill the whole or part of Tasmania may be declared an area free of GMOs if it ‘would aid in preserving the identity of non-genetically modified crops and animals for marketing purposes’.[258] A substantial fine is imposed on those who deal with[259] GMOs in a GMO-free area without a permit under the Bill[260] and a licence under the GT regulatory scheme.[261] When deciding whether to grant a permit, the likely impact on market access for non-GMOs must be considered.[262] There is no provision though regarding when an impact will be adverse and, presumably, justify refusal of a permit.
The Act does not require intention for there to be an offence. However, there is some provision for those who inadvertently deal with GMOs. Such people can be ordered to destroy the GMO.[263] They can then seek compensation under the Act for loss or damage suffered as a result of the destruction.[264] Where the legislation is contravened[265] and the person responsible can be identified, directions to rectify matters giving rise to the contravention can be made.[266] It is unclear whether this allows directions that compensation be paid (or repaid) by the commercialiser to the contaminated party. It seems unlikely as such compensation is not a matter ‘giving rise to the contravention’. It is a consequence of a contravention. However, the need for compensation (or repayment of it to the Government) could be prescribed as a matter to be rectified.[267]
In 2000 Victoria investigated ‘the potential to label products sourced in particular areas of Victoria as ‘GEFZ’ products – that is, they come from Genetic Engineering Free Zones’.[268] It concluded that statutory, regional GM-free zones would not be established.[269] The Victorian Government nevertheless announced on 8 May 2003 that there would be a twelve month moratorium on the commercial production of GM canola in Victoria.[270] The Government entered into an extra-legislative agreement with the companies wanting to release GM canola to that effect.[271] An independent reviewer was appointed in November 2003 to advise the Victorian Government on the marketing impacts of the commercial release of GM canola.[272] The reviewer’s report recommended, inter alia, a limited release of GM canola for a trial period beginning in 2004.[273] Despite this, on 25 March 2004 the moratorium on commercial releases of GM canola was extended until at least 2008.[274]
On 31 March 2004, the Control of Genetically Modified Crops Bill 2004 was introduced into the Legislative Assembly. The legislation came into operation on 12 May 2004. The Act is generally the same as the legislation in other jurisdictions. The Minister may make an order designating all or part of Victoria as GM-free for all or certain crops or, conversely, order that GM crops may be grown in that area.[275]
GMOs regulated by the legislation are GM crops. These are crops that consist of or include GM plants.[276] Plant includes all plants, whether food plants or otherwise.[277] It also includes seed or other parts of the plant. Accordingly plants and their parts to be used as animal feed are included. The cultivation[278] of GM canola, although licensed by the GTR, is prohibited until 29 February 2008.[279]
It is an offence to cultivate or otherwise deal with a GM crop in contravention of an order if the person knows or is reckless as to whether the crop is a GM crop.[280] As in SA, threshold amounts for the presence of a GMO in crops can be determined by the Minister.[281] GMO amounts less than the threshold are then to be disregarded for the purposes of the Act.[282] Crops cultivated in contravention of the Act can be destroyed.[283] However, this requires an order by the Magistrates Court.[284] There is no provision for compensation. There is though a defence of due diligence.[285] Offenders must prove they took reasonable precautions and exercised due diligence to prevent the offence to use it.
The Act creates a further offence of particular relevance to GMO commercialisers. Providing a GMO to another person where the provider[286] knows or had reasonable cause to know that the other person intended either to contravene an order or to pass the GMO to someone else to do so, is an offence.[287]
The WA Cabinet has passed legislation to reinforce its policy of a five year moratorium on commercial plantings of GM food crops.[288] That legislation, the Genetically Modified Crops Free Areas Act 2003, gives the responsible Minister power to issue an order designating an area free of all GM crops.[289] The legislation applies only to plants.[290] On 22 March 2004 the Premier announced that all of WA would be declared a GM-free area[291] to ‘protect the State’s “clean and green” status’.[292]
Under the legislation it is an offence to ‘cultivate’[293] GM crops in a designated area.[294] However, there must be an intentional release to the environment.[295] Further, the ‘offender’ must know or be reckless as to whether the crop is a GM crop.[296] Finally, the moratorium does not apply to field trials licensed under the GT Act.[297] If a person is convicted under the legislation and another person has suffered loss or damage because of the offence, the offender can be ordered to compensate that other person.[298] Crops inadvertently contaminated by a GMO can be destroyed.[299] Compensation is available to the owners of such crops.[300] This is subject to it being just[301] and the person not having been successfully prosecuted under the Act.[302] Offenders responsible for the contamination may then be ordered to repay the Government the costs of such destruction or compensation.[303] The Act is to be reviewed after five years.[304]
The State responses to the threat of contamination are obviously very relevant to the commercialisation of GMOs. They affect whether and how releases can proceed. All GMO commercialisers will need to comply with at least some State imposed limitations. Commercialisers of GM pigs would, for example, need be concerned in such regard only in Tasmania.[305] Release of GM carnations, as a non-food plant, is restricted in WA and Tasmania. Release of GM canola, however, is restricted in all States but Queensland and the NT.[306] Failure to comply with State restrictions can, depending upon the jurisdiction, result in fines, imprisonment or both.
The State legislation exposes commercialisers to new offences if GMO releases occur in designated areas. Importantly, in SA, WA and perhaps Tasmania[307] it also creates a new statutory liability to compensate those harmed by the cultivation of a GM crop. The State regulations also go further than the GT Act because they provide for the destruction of a third party’s organisms contaminated by a GMO.[308] In ACT and NSW third parties can also be restricted in the future use of their land.
As noted in Part V, many concerns additional to those considered by the GTR are relevant to whether GMO releases should proceed. Whether those concerns, particularly the economic effect of GMO releases on trade in non-GMOs, are legitimate is debateable but it seems that most States want more time to consider them.[309] The legislation gives them that time. However, despite being in response to concerns about effects other than human health, safety and risk to the environment, the legislation does little to clarify how those risks will be assessed or when they will be acceptable. It is disappointing that the States did not take the opportunity to clarify these matters. Further, all but two States failed to clarify when a contaminated crop will be ‘GM’ for these purposes. These failings will, it is predicted, have important repercussions in common law proceedings following GM contamination and only add to the confusion facing GMO commercialisers.
That the position in some or all States may change with or without a change in Government further adds to the confusion of those trying to commercialise GMOs in Australia. In Victoria, for example, it seems that a change of Government would see a change of approach.[310] In SA though, a change of Government is unlikely to result in a lifting of the moratorium.[311] What will happen on the expiry of the various legislation is also difficult to predict. That GMOs will not respect State boundaries means differences in approach between the States is a further complication for commercialisers.
|
ACT
|
NSW
|
SA
|
TAS
|
VIC
|
WA
|
---|---|---|---|---|---|---|
LEGISLATION
|
[also GMO (Environment Protection) Bill 2003 - not included in Table]
|
[also Gene Technology (Responsibility for the Spread of Genetically
Modified Plant Material) Bill 2003 - not included in Table]
|
Current: Plant Quarantine Act 1997
Proposed: Genetically Modified Organisms Control Bill 2004
|
|||
GM TYPE AFFECTED
|
GM food plants
|
GM food plants
|
GM food and animal feed plants
|
Current: Prescribed GM plants and their products
Proposed: All GMOs under GT Act
|
GM plants
|
GM plants
|
OFFENCE
|
Cultivating GMO in ACT knowing or being reckless as to whether it is a GMO
and whether it contravenes a moratorium order, without
exemption
|
Cultivating GMO in NSW knowing or being reckless as to whether it is a GMO,
without exemption
|
Cultivating GMO in SA without exemption
|
Current: Moving GMO into Tas for intentional release in open
environment
Proposed: Dealing with GMO in GMO-free area without permit and GTR
licence
|
Cultivating GMO in Vic knowing or reckless as to whether it is a GM crop,
without exemption
|
Intentionally releasing into environment and cultivating GM crops in WA,
knowing or reckless as to whether it is a GM crop, without
exemption
# does not apply to GTR licensed field trials
|
PENALTY
|
Fine, imprisonment or both
|
Fine, imprisonment or both
|
Fine
|
Current: fine
Proposed: fine
|
Fine
|
Fine
|
INADVER-TENT OFFENDERS
|
#intention required
# crop can be destroyed and future use of land can be restricted
# limited compensation available from Govt
|
#intention required
# crop can be destroyed and future use of land can be restricted
# no compensation available
|
# intention not required
#defence – no action in SA against inadvertently contaminated farmers
(subject to certain conditions being met)
# crop can be destroyed
#compensation available from Govt and commercialiser can be ordered to
repay Govt
# convicted offenders can be ordered to compensate ppersons harmed by
offence
|
Current:
# intention not required
#defence if taken all reasonable action and care to avoid offence
# crop can be destroyed
# no compensation available
Proposed:
# intention not required
# can be ordered to destroy GMO
#compensation available from Govt
# no provision for repayment but can be ordered to repay Govt destruction
costs
|
#intention required
#defence – due diligence
# crop can be destroyed on order of Court
# no compensation
|
# intention required
#crop can be destroyed
#compensation available from Govt and commercialiser can be ordered to
repay Govt
# convicted offenders can be ordered to compensate persons harmed by
offence
|
ABILITY TO SET ‘GM’ THRESHOLD
|
No
|
No
|
Yes
|
No
|
Yes
|
No
|
REVIEW/ EXPIRY
|
If enacted, expires 17 June 2006
|
Act expires 3 March 2006
|
Review by 29 April 2007
|
Proposed: Govt policy to review by 30 June 2008
Current: No provision for review/expiry
|
Order with respect to GM canola expires 29 February 2008
|
Review after 24 December 2008
|
STATE
|
GM CANOLA
|
GM CARNATION
|
GM PIG
|
---|---|---|---|
ACT
NOTE: Gene Technology (GM Crop Moratorium) Bill 2003 only
considered
|
# Prohibited
#Penalty – fine, imprisonment or both
|
Non-food plant therefore legislation inapplicable
|
Not applicable
|
NSW
|
# Prohibited although limited exemptions have been
granted
# Penalty – fine, imprisonment or both
|
Non-food plant therefore legislation inapplicable
|
Not applicable
|
NT
|
No moratorium
|
No moratorium
|
No moratorium
|
QLD
|
No moratorium
|
No moratorium
|
No moratorium
|
SA
NOTE: a second Bill makes those with proprietary interest in
GM plants liable to owners/occupiers of land who suffer loss or damage
because
of GMO spread
|
# Prohibited although limited exemptions have been
granted
#Penalty - fine
|
Non-food plant therefore legislation inapplicable
|
Not applicable
|
TAS
|
# Current: Prohibited
# Penalty – fine
# Proposed: Prohibited
# Penalty - fine
|
# Current: not applicable
# Proposed: Prohibited
# Penalty - fine
|
# Current: not applicable
# Proposed: Prohibited
# Penalty – fine
|
VIC
|
# Prohibited
# Certain GTR licensed releases automatically exempted
# Penalty - fine
|
Applicable but not covered by current order
|
Not applicable
|
WA
|
# Prohibited
# GTR licensed field trials allowed
# Penalty - fine
|
# Prohibited
# GTR licensed field trials allowed
# Penalty – fine
|
Not applicable
|
Significant uncertainty for GMO commercialisers arises with respect to the risks considered by the GTR in making licensing decisions. The GTR considers that social and economic implications of GMO releases are outside the ambit of relevant considerations. From a commercialiser’s perspective this may seem advantageous because it means the GTR’s assessment is essentially a scientific one and considers only risks to a narrow range of interests. However, some value judgments still need to be made even in the current form of assessment. Further, it has been submitted that the Regulator’s approach is incorrect. Any risk, including risk to other forms of agriculture, can and should, it has been argued, be considered by the GTR when making licensing decisions. It has also been submitted that a broader range of matters fall within the term ‘environment’ than the GTR currently allows. In particular, it has been submitted that non-GM farming is part of the environment. Therefore risks to such parts of the environment could lawfully justify refusal of a licence by the GTR.
Such an approach may seem contrary to GMO commercialisers’ commercial interests. However, that the GTR does not take into account social or economic considerations in conducting risk assessments under the GT Act is disadvantageous to commercialisers for two main reasons. First, the uncertainty regarding the correctness of the GTR’s approach leaves her decisions vulnerable to attack via judicial review. Secondly, that exclusion has weakened the national regulatory scheme. It has set the scene for the majority of States to impose moratoriums and new legal obligations on commercialisers, meaning there are now non-uniform requirements for GMO releases throughout Australia. As McGrath concludes:
[F]ailure of the Act to assess these market issues has meant the disintegration for the time being of the nationally consistent scheme. The proposed Policy Principle will entrench the ability of the States and territories to maintain unilateral approaches to the utilisation of GM crops.[312]
The new State legislation and the recently commenced review of the risk assessment process under the GT Act[3] make it timely to consider now how these significant legal challenges will affect the use of agricultural GMOs in Australia. It is suggested that the best solution for GMO commercialisers would be for the GTR to consider all risks, including social and economic risks, arising from GMO releases. However, this will require the States to surrender their power to regulate to protect their local trade. This seems unlikely at this time.
[*] Lecturer, Faculty of Law, Monash University.
[p] The ACT moratorium legislation was enacted after the completion of this article, commencing on 10 July 2004. References to it in this article are to the Bill. Some amendments were made prior to enactment.
[1] Andrew Bolt, ‘Modify your ideas, Bracks’, Sunday Herald Sun (Melbourne), 28 March 2004, 21 quoting Dr Richard Norton, University of Melbourne, School of Agriculture and Food Systems.
[2] In this study ‘States’ includes all Australian States and Territories unless otherwise indicated.
[3] Victoria Laurie, ‘State cultivates a new attitude to genetically modified crops’, The Weekend Australian (Sydney), 15-16 May 2004, 9.
[4] For a more detailed discussion of GM see Bernard Glick and Jack Pasternak, Molecular Biotechnology: Principles and Applications of Recombinant DNA (3rd ed, 2003).
[5] Some viruses have ribonucleic acid (RNA) instead of DNA as their genetic material.
[6] Commonwealth, House of Representatives Standing Committee on Primary Industries and Regional Services, Work in Progress: Proceed with Caution. Primary Producer Access to Gene Technology (June 2000), [6.2].
[7] Genetic contamination is really a subset of physical contamination but will be treated separately here.
[8] Contamination may also occur through, for example, physical intermingling in the supply chain during processing, transporting or distribution.
[9] Dispersal could occur, for example, through wind, insects, bees or other animals.
[10] For example food legislation does not require meat from such organisms to be labelled as GM and the GT Act does not apply to such animals. See Australia New Zealand Food Standards Code, Standard 1.5.2 Editorial note. With respect to the GT Act see below Part IV(a).
[11] Australian Quarantine Inspection Service, Organic Produce Export Committee, National Standard for Organic and Bio-Dynamic Produce (3rd ed, December 2002), Standard 3.13.1. See also Standard 3.13.7d.
[12] For summary of factors relevant to cross-pollination see SA, Department of Human Services, Environmental Health Branch, Genetically Modified Food Unit, Discussion Paper, Preserving the Identity of non-GM Crops in South Australia (2001), 18. For scientific assessment of literature on cross-pollination in Australia and overseas see J Glover, Gene flow study: Implications for GM crop release in Australia (Bureau of Rural Sciences, Canberra, 2002).
[13] Victoria, Genetic Engineering-free Zones. Report of the Victorian Government Consultation (December 2001), 12.
[14] Victoria, Department of Natural Resources and Environment, Consultation paper, Genetic engineering-free zones (March 2001), submission by Florigene Ltd.
[15] Both the Gene Technology Regulator (‘GTR’) and her predecessor the Genetic Manipulation Advisory Committee (‘GMAC’) have concluded that the probability of gene dispersal from cultivated carnations is very low. See Office of the Gene Technology Regulator (‘OGTR’), Risk Assessment and Risk Management Plan for Intentional Release of a GMO Into the Environment: Application No. DIR 030/2002, Executive Summary (14 March 2003) 2 and GMAC, Annual Report 1997-8 (AGPS, Canberra, 1999), 19 ‘Proposed PR-84’ respectively.
[16] For this reason carnations are vegetatively propagated (by cuttings) but do not spread vegetatively under natural conditions.
[17] Nonsexual transfer is possible from one unrelated organism to another by virus or bacteria via horizontal transfer. Gregory Mandel, ‘Gaps, Inexperience, Inconsistencies, and Overlaps: Crisis in the Regulation of Genetically Modified Plants and Animals’ (June 19 2003) (available at http://ssrn.com/abstract=418221), 21.
[18] Maria Lee and Robert Burrell, ‘Liability for the Escape of GM Seeds: Pursuing the “Victim”?’ (2002) 65 Modern Law Review 517, 518. Contra see below n 29.
[19] See Work in Progress Report above n 6, [4.18].
[20] The plant was not GM but was created with human intervention through mutagenesis.
[21] Mary Rieger et al, ‘Pollen-mediated movement of herbicide resistance between commercial canola fields’ (2002) 296 Science 2386. See also Erik Stokstad, ‘A little pollen goes a long way’ (2002) 296 Science 2314.
[22] Stokstad above n 21, 2314. About 63% of the fields tested turned up some plants with modified genes although the highest rate of modified plants in non-modified fields was only 0.2%. Rieger above n 21.
[23] Such precautions include the establishment of buffer zones or other barriers around a property or changes in crop selection or farming practices.
[24] Such as the State legislation discussed in Part VI below.
[25] See, eg, the well known case of Monsanto Canada Inc v Schmeiser 2004 SCC 34 (21/5/04) (Can).
[26] For example a gene endowing herbicide resistance may transfer from the GMO to a weed and the weed may then become difficult to control requiring changes in weed management techniques.
[27] Australian anti-GM activist groups, Australian GeneEthics Network and Greenpeace Australia-Pacific, have reportedly been unable to find organic canola farmers in Australia. G O’Neill, ‘Melbourne University report positive on GM Canola varieties’ Australian Biotechnology News, 26 March 2003 <http://www.biotechnews.com.au/index.php?id=1387312272 & taxid=5.>
[28] See Richard Repp, ‘Biotech Pollution: Assessing Liability for Genetically Modified Crop Production and Genetic Drift’ (2000) 36 Idaho Law Review 585, 594-5 with respect to the repercussions this may have for organic farmers.
[29] The Victorian Government has found that markets are generally not willing to pay a premium for non-GM products. Premiums for non-GM products are, at best, only niche sales in the context of global production and world markets. Genetic Engineering-free Zones Report above n 13, p 10. See also WA, Department of Agriculture, International Market Trends for Genetically Modified Crops (Perth, February 2002) <www.agric.wa.gov.au/biotechnology/market_200202.htm>; Max Foster et al, Market Access Issues for GM Products: Implications for Australia, ABARE e Report 03.13 to the Department of Agriculture, Fisheries and Forestry – Australia (Canberra, July 2003); Max Foster, GM Canola – What are its Economics under Australian Conditions (Australian Bureau of Agricultural and Resource Economics, 2003) <http://abareonlineshop.com/product.asp?prodid=12526> which also concluded that there was no clear trend emerging for significant premiums for differentiated (GM and non-GM) products; Peter Lloyd, Report of the Independent Reviewer to the Government of Victoria: Review of Market Impacts of Genetically Modified Canola and Industry Preparedness (2004) for a discussion of premiums paid on non-GM crops by overseas markets.
[30] Parliament of Tasmania, Joint Select Committee Report on Gene Technology (2001) 87.
[31] Australian Government Department of Agriculture, Fisheries and Forestry, Science and Economic Policy Branch, Liability Issues Associated with GM Crops in Australia (scoping study)(September 2003), p 6.
[32] For a summary of GM legislation and labelling issues concerning the export of Australian produce to 15 overseas countries see WA, Department of Agriculture paper, above n 29, pp 62-3 Table 21.
[33] Thomas Redick and Christina Bernstein, ‘Nuisance Law and the Prevention of “Genetic Pollution”: Declining a Dinner Date with Damocles’ (2000) 30 Environmental Law Reporter 10328, text re fn 11. See also Repp above n 28, 591 where events leading to rejection of shipment of organic tortilla chips worth US$500,000 by European authorities because DNA testing showed traces of GM corn are described. The manufacturer claimed that pollen from GM corn in nearby fields was the probable cause. See also with respect to this case A Bryan Endres, ‘”GMO:” Genetically Modified Organism or Gigantic Monetary Obligation? The Liability Schemes for GMO Damage in the United States and the European Union’ (2000) 22 Loyola LA International & Comparative Law Review 453, 456 and 482.
[34] That regulation was first by the Recombinant DNA Monitoring Committee (‘RDMC’). In 1987 the GMAC took over responsibility. A further body, the Interim Office of the Gene Technology Regulator (‘IOGTR’), worked with GMAC in the more recent past.
[35] Parliament of the Commonwealth of Australia, Genetic Manipulation: The Threat or the Glory? Report by the House of Representatives Standing Committee on Industry, Science and Technology (AGPS, Canberra, 1992).
[36] GMAC, Annual Report 1993-4 (AGPS, Canberra, 1994) 12.
[37] Peter Quiddington, ‘New, lean porkers have the regulators hamstrung’, The Australian Financial Review (Sydney), 24 November 1995, 19.
[38] Commonwealth Senate Committee on Community Affairs, A Cautionary Tale: Fish Don’t Lay Tomatoes. A Report on the Gene Technology Bill 2000 (November 2000) Tabled 1/11/00 PP No 263/00, [1.8]. GM is one type of gene technology.
[39] Ibid, [1.10].
[40] Ibid, [1.11] fn 3.
[41] Entitled Proposed national regulatory system for genetically modified organisms. How should it work? See ibid, [1.11].
[42] Senate Committee on Community Affairs, above n 38, [1.12].
[43] Together with a plain language explanatory guide.
[44] Senate Committee on Community Affairs, above n 38, [1.12].
[45] See First Australian Consensus Conference, Gene Technology in the Food Chain, Lay Panel Report (National Museum of Australia, Canberra, 1999); Work in Progress Report, above n 6.
[46] Senate Committee on Community Affairs, above n 38, [1.13]. An amended Explanatory Memorandum and Explanatory Guide dated July 2000 were also released.
[47] Senate Committee on Community Affairs, above n 38. See also draft Gene Technology Regulations 2000 and accompanying Explanatory Guide, August 2000; revised draft Gene Technology Regulations January 2001 and Explanatory Guide in relation to the development of the scheme.
[48] Two other associated Commonwealth Acts also came into force on that day which are considered part of the national scheme – the Gene Technology (Consequential Amendments) Act 2000 and Gene Technology (Licence Charges) Act 2000. No fees or charges are currently imposed for licences and other approvals or actions under the regulatory scheme.
[49] See GT Act s 5.
[50] The relevant Bill has been introduced to the WA Parliament. Gene Technology Bill 2001 (WA).
[51] Gene Technology Act 2003 (ACT); Gene Technology (New South Wales) Act 2003 (NSW); Gene Technology Act 2001 (Qld); Gene Technology Act 2001 (SA); Gene Technology Act 2001 (Tas); Gene Technology Act 2001 (Vic).
[52] Gene Technology Regulations 2004 (ACT); Gene Technology Regulation 2002 (Qld); Gene Technology Regulations 2002 (SA); Gene Technology Regulations 2003 (Tas); Gene Technology Regulations 2001 (Vic).
[53] Any variation, however, must be consistent with those allowed by the GT Agreement.
[54] Gene Technology (New South Wales) Act 2003 (NSW) s 6(1).
[55] That other legislation being the Gene Technology (GM Crop Moratorium) Act 2003 (NSW) (‘NSW GM Act’). That legislation is discussed in Part VI below. See also Genetically Modified Organisms Control Bill 2004 (Tas) Schedule 1.
[56] Commonwealth, Department of Health and Ageing, OGTR, Quarterly Report of the Gene Technology Regulator for the period 1 October to 31 December 2001 (13 May 2002), 10.
[57] Including arrangements for the reimbursement of costs incurred by jurisdictions for services provided as part of the legislative scheme.
[58] These points are from Commonwealth, OGTR, Handbook on the Regulation of Gene Technology in Australia, 22-4. The GTMC is discussed further below in Part V.
[59] GT Act s 3.
[60] See GT Act s 10(1) ‘deal with’ and the discussion in this Part below.
[61] GT Act ss 32(1) and 33(1).
[62] GT Act ss 32(1)(a) and 33(1)(a).
[63] See GT Act Part 10.
[64] GT Act s 10(1) ‘GMO’ and ‘genetically modified organism’.
[65] GT Act s 10(1) ‘organism’.
[66] GT Act s 10(1) ‘gene technology’.
[67] Those organisms declared not to be GMOs are set out in Gene Technology Regulations 2001 (Cth) Schedule 1 Part 1. For examples of such organisms see Handbook above n 58, 34-35, Box 1.
[68] Commonwealth, Regulation Impact Statement for the Gene Technology Regulations 2001, Part 4, attachment to Gene Technology Regulations 2001 Explanatory Statement.
[69] Ibid.
[70] Protoplast fusion occurs when the outer cell walls are removed from single cells from two types of plant (the cells having been grown in tissue culture). The resulting ‘protoplasts’ are then fused, and some genetic exchange between the two nuclei may occur. Plants can then be regenerated from the fused cells, which may have newly acquired characteristics.
[71] Gene Technology Regulations 2001 (Cth) Schedule 1, Part 1.
[72] A somatic cell is any cell in a multicellular organism that is not a gamete (that is, not an egg or sperm cell). Somatic cell transfer is the process by which the nucleus from a somatic cell is fused with an egg cell from which the nucleus has been removed. After fusion, the cell can go on to develop even into an entire organism.
[73] Gene Technology Regulations 2001 (Cth) reg 4. Note though that cloning of human beings is prohibited pursuant to the Prohibition of Human Cloning Act 2002 (Cth) and complementary State legislation.
[74] Handbook above n 58, 32.
[75] GT Act s 10(1) ‘deal with’.
[76] See GT Act s 10(1) ‘Regulator’. The Commonwealth Senate Committee of Community Affairs had recommended that the Regulator be a statutory authority consisting of a Board of three people. See Fish Don’t Lay Tomatoes Report above n 38, p xiv. Nevertheless, the GTR is an individual.
[77] The Office is a Commonwealth regulatory agency within the Therapeutic Goods Administration of the Commonwealth Department of Health and Aged Care. The GTR is appointed by the Governor-General with the agreement of the majority of Australian jurisdictions. GT Act s 118.
[78] The current GTR is Dr Sue Meek.
[79] GT Act s 30.
[80] GT Act s 28.
[81] The GMO Register is maintained by the Regulator (GT Act s 76(2)). It may be kept in a computerised form (GT Act s 76(3)) and is open to public inspection (GT Act s 81).
[82] GT Act s 43(2). See Gene Technology Regulations 2001 (Cth) reg 7. Schedule 4 of the Regulations sets out the prescribed information required in licence applications.
[83] GT Act s 43(2)(e). See also s 57(1).
[84] GT Act s 57(2). See also s 58.
[85] GT Act Act s 58. Other matters include the applicant’s past history with other licences or permits issued under any Australian (federal or state) or foreign law where the law concerns the health and safety of people or the environment and the applicant’s capacity to meet the conditions of the licence. This presumably includes matters such as the applicant’s financial capacity.
[86] It must also have occurred within the prior 10 years and have been punishable by a fine of $5000 or more or imprisonment of one year or more. GT Act s 58(3).
[87] GT Act ss 42 and 43(2)(d).
[88] GT Act s 40(3).
[89] GT Act Part 5.
[90] However, the actual assessment processes and licence conditions finally imposed will differ in those cases. For example, for a licence relating to the commercial release of a GMO, the Regulator will most likely require to be satisfied that the GMO’s safety has already been tested in Australia through licensed field trials. Handbook above n 58, 91-92. This will not be necessary for applications in respect of limited release for field trial purposes.
[91] GT Act s 11.
[92] GT Act s 10.
[93] GT Act s 55.
[94] GT Act s 56. A review of a decision to refuse a licence or impose particular conditions on a licence can be sought by an applicant. GT Act Part 12 Div 2.
[95] OGTR, Risk Analysis Framework for Licence Applications to the Office of the Gene Technology Regulator (January 2002), 16.
[96] OGTR, Risk Assessment and Risk Management Plan for Intentional Release of a GMO Into the Environment: Application No. DIR 030/2002, Executive Summary (14 March 2003).
[97] OGTR, Risk Assessment and Risk Management Plan for Commercial Release of Bayer GM Canola into the Environment: Application No. DIR 021/2002 (1 April 2003).
[98] OGTR, Full Risk Assessment and Risk Management Plan for Application for licence for dealings involving an intentional release into the environment. DIR 021/2002 (25 July 2003), 11.
[99] OGTR, Risk Assessment for DIR 021/2002 above n 97.
[100] There is some support for her view that she cannot consider the economic ramifications of the commercial production of GM crops on neighbouring farmers. See Nicole Rogers, ‘Seeds, Weeds and Greed: An Analysis of the Gene Technology Act 2000 (Cth), Its Effect on Property Rights, and the Legal and Policy Dimensions of a Constitutional Challenge’ [2002] MqLawJl 1; (2002) 2 Macquarie Law Journal 1, 2.
[101] OGTR, Risk Assessment for DIR 021/2002 above n 97. The GTR also noted that she had consulted with the authorities prescribed in the Act. Ibid.
[102] OGTR, Licence Application DIR021/2002.
[103] The Gene Technology Community Consultative Committee recommended on 20 February 2003 that application DIR021/2002 be declined because ‘a state of community unreadiness exists concerning the risks to the environment of the commercial release of GM canola’. Gene Technology Community Consultative Committee, Communique of 4th GTCCC meeting 20 February 2003.
( <http://www.ogtr.gov.au/committee/gtccc.htm accessed 4/5/04> ). (This Committee is one of three advisory committees established under the Act. See GT Act s 106. See also Gene Technology Regulations 2001 (Cth) Part 5 with respect to this Committee.)
[104] It could not be grown even if licensed, where it would be contrary to State law to do so.
[105] OGTR, Full Risk Assessment for DIR021/2002, above n 98, 7.
[106] Exemptions and permits allowing limited releases can be obtained under the legislation. See Part VI below.
[107] Charles Lawson, ‘Risk Assessment in the Regulation of Gene Technology under the Gene Technology Act 2000 (Cth) and the Gene Technology Regulations 2001 (Cth)’ (2002) 19 Environmental and Planning Law Journal 195, 202 and 211. See also Rogers above n 100, 9.
[108] OGTR, Risk Analysis Framework above n 95, 15.
[109] For eg, ibid, 14.
[110] Lawson above n 107, 202. See also Mark Tranter, ‘A question of confidence: an appraisal of the operation of the Gene Technology Act 2000’ (2003) 20 Environmental and Planning Law Journal 245, 253-4.
[111] See also GT Act s 57 which requires a licence to be refused if it would be contrary to a policy principle or the applicant is not a suitable person.
[112] GT Act s 56(1).
[113] See GT Act s 3.
[114] GT Act s 56(2)(a) and (b). Submissions by the public and other bodies required to be consulted under the legislation as well as any policy guidelines must also be considered. Section 56(2)(c) and (d). See also s 57. Cf DNIR applications where although RARMPs must be prepared (s 47) they are not required to be considered in approval decisions (s 56). This does not mean the Regulator cannot take a DNIR RARMP into account. As observed by Tranter, this appears to be an omission. Tranter above n 110, 249.
[115] Emphasis added. GT Act s 47(2) (re DNIR applications) and s 51(1)(a) (re DIR applications).
[116] Emphasis added. GT Act s 56(1).
[117] During a Senate Committee review of the Gene Technology Bill it was recommended that the Bill require that the GTR not issue a DIR licence without conditions ensuring, as much as possible, that contamination of non-GM produce or land cannot occur. Senate Committee on Community Affairs, above n 38, xiv. This was not done.
[118] OGTR, Full Risk Assessment for DIR021/2002, above n 95.
[119] Ibid, Appendix 1, 70.
[120] Ibid, Appendix 1, 70. See also definition of ‘hazard’.
[121] Ibid, 13.
[122] For an evaluation of some of the concerns expressed with respect to the GT Act generally, see Monique Hain et al, ‘Regulating Biosciences: the Gene Technology Act 2000’ (2002) 19 Environmental and Planning Law Journal 163.
[123] Explanatory Memorandum, Gene Technology Bill 2000 n 4, 6. Work in Progress Report above n 6, 150 notes that the interim arrangements immediately before the GTR was established required GMAC to examine the risks posed by each application to public health, the environment or the sustainability of agricultural systems (emphasis added).
[124] Explanatory Memorandum above n 123, 6.
[125] Although information which could be used to assess risks in that regard is required from the applicant. For example, information on where the GMO is to be released, cross-pollination between the parent plant and the GMO and ‘other possible adverse consequences’ is required. OGTR, Risk Analysis Framework above n 95, 43, 47 and 48.
[126] Ibid 28.
[127] Tranter above n 110, 253.
[128] GT Act s 10.
[129] Chris McGrath, ‘A system under strain: The Regulation of Gene Technology’ (2003) 2 National Environmental Law Review 32, 35.
[130] GT Act s 51(1)(a).
[131] GT Act s 49(2)(c).
[132] GT Act s 49(2)(d).
[133] GT Act s 51(1)(g).
[134] Gene Technology Regulations 2001 (Cth) reg 10(1)(b)(i) to (iv).
[135] Lawson above n 107, 209.
[136] Ibid, 209-210.
[137] McGrath above n 129, 35.
[138] Work in Progress Report above n 6, [7.66].
[139] The points in this paragraph are from Cth, IOGTR, Discussion Paper: Proposed National Regulatory System for Genetically Modified Organisms: How Should it Work? (1999), 29, section 4.9.
[140] Each jurisdiction can decide which Minister will represent them – eg, health, environment or agriculture Minister. Handbook above n 58, 23.
[141] It also considers changes to the national legislative framework as required and advises on the appointment and dismissal of the GTR and the chairpersons of the advisory committees. Cth, OGTR, Information Sheet, ‘Questions and Answers on the Gene Technology Act 2000’, 6. See also Handbook above n 58, 23.
[142] GT Act ss 21 and 22. The others are policy guidelines (GT Act s 23. See also s 56 which requires the GTR to have regard to such guidelines in making licensing decisions) and codes of practice (GT Act s 24(1)). Policy guidelines are guidance notes and advisory only (Handbook above n 58, 15). Codes of practice guide applicants in their work with GMOs (Handbook above n 58, 21). Codes of practice may be applied by the Regulator as conditions of licence. (Ibid, 21).
[143] GT Act s 57(1) and Gene Technology Regulations 2001 (Cth) cl 2.1 Sch 3.
[144] At its first meeting on 24 May 2002, the GTMC agreed to prepare a policy principle recognising areas designated under State law as being for either GM or non-GM crops for marketing purposes. See Gene Technology Standing Committee Introductory Paper ‘Policy Principle to Recognise GM/Non-GM Designated Areas’ (16/4/03); draft policy principle ‘Gene Technology (Recognition of Designated Areas) Principle 2003’; draft Explanatory Memorandum and draft Regulatory Impact Statement.
[145] Gene Technology Ministerial Council, Joint Communique 31 July 2003 (available as Appendix A to OGTR, Quarterly Report of the Gene Technology Regulator for the period 1 July to 30 September 2003 (2003)). The Policy Principle was gazetted in Commonwealth Government Special Gazette No S340 on 5 September 2003 and tabled in both Houses of Parliament on 9 September 2003. With respect to commencement, see Gene Technology (Recognition of Designated Areas) Principle 2003 s 2. For background on this issue see Senate Committee on Community Affairs, above n 38, [6.33]-[6.88].
[146] Designated Areas Policy Principle s 4. ‘State’ includes the Territories. Section 5 provides that:
An area is recognised as an area that is designated for the purpose of preserving the identity of GM crops, non-GM crops, or both GM crops and non-GM crops, for marketing purposes, if the area is so designated under a State law.
[147] Gene Technology Standing Committee, Regulatory Impact Statement on Gene Technology (Recognition of Designated Areas) Principle 2003 s 1.1. Section 6, page 16 of that Statement states that the Policy Principle will apply only to licences for the commercial release of GMOs. However, it would seem from the rest of the Statement that this includes field trial releases.
[148] Explanatory Statement re Gene Technology (Recognition of Designated Areas) Principle 2003.
[149] Designated Areas Policy Principle s 7.
[150] Regulatory Impact Statement above n 147, s 1.1.
[151] GT Act s 21(1)(aa).
[152] Regulatory Impact Statement above n 147, s 1.1.
[153] Ibid, s 2.
[154] Designated Areas Policy Principle s 6. It is outside the scope of this article to consider whether or not a State should introduce such a Principle. However, the Gene Technology Standing Committee notes issues that may arise from designating such areas include ‘compensation issues, administration costs and compliance with National Competition Policy or World Trade Organization (WTO) agreements’. See Regulatory Impact Statement above n 147, s 5.1.
[155] With respect to some of the matters that any such legislation would need to address see Regulatory Impact Statement above n 147, s 5.2.
[156] See, for example, in the case of Victoria, Victoria, Parliamentary Debates, Legislative Assembly, 9 April 2003, p 963 (Savage, Member for Mildura).
[157] Queensland has developed a Code of Ethical Practice for Biotechnology in Queensland, effective 1 September 2001 but has not banned the release of GMOs in that State. Queensland, Department of Innovation and Information Economy, Code of Ethical Practice for Biotechnology in Queensland (1 September 2001).
[158] The NT Government’s pre-election position on GMOs was to oppose any commercial development but support ongoing experimentation and testing. NT, Parliamentary Debates, 15 August 2002, Ninth Assembly, First Session Parliamentary Record No: 6 (McAdam, Minister for Business, Industry and Resource Development). No formal moratorium has been introduced.
[159] In SA the order is made by the Governor on the recommendation of the Minister. See Genetically Modified Crops Management Act 2004 (SA) s 5(2) (‘SA GM Act’).
[160] Orders may also be made that specify that certain GMOs cannot be grown in a particular area or designate an area as one in which GMOs may be grown. See Gene Technology (GM Crop Moratorium) Bill 2004 (ACT) cl 7(1) (allowing prohibition of stated GM plants in all the ACT) (‘ACT GM Bill’); SA GM Act s 5(1); Plant Quarantine Act 1997 (Tas) s 8 (‘Tas PQ Act’); Control of Genetically Modified Crops Act 2004 (Vic) cl 4(1) (‘Vic GM Act’); Genetically Modified Crops Free Areas Act 2003 (WA) s 4 (‘WA GM Act’). Tasmania’s new Bill does not allow for this. See Genetically Modified Organisms Control Bill 2004 (Tas) cl 5(1) (‘Tas GM Bill’). In NSW the prohibition must be of a specified GMO or class of GMO in all of the State. NSW GM Act s 6.
[161] ACT GM Bill cl 8; NSW GM Act s 8; SA GM Act s 6; Tas PQ Act s 38; Tas GM Bill Part 3 Div 1; Vic GM Act s 6; WA GM Act s 6.
[162] Some prerequisites for the granting of exemptions or permits are specified in two States. See SA GM Act s 6(2); Tas GM Bill cl 9.
[163] There must be consultation with the public (see SA GM Act s 5(3)) and an Advisory Committee (see SA GM Act s 5(8)). See Part 3 Div 1 with respect to that Committee.
[164] In NSW, there must be consultation with an Advisory Council created under the Act. See NSW GM Act s 8(2). With respect to the Advisory Council see s 13. In SA consultation with an Advisory Committee is required. See SA GM Act s 6(3).
[165] Tas GM Bill cl 9(2)(b).
[166] The relevant provisions are described below.
[167] SA GM Act s 4(1); Vic GM Act s 7(1).
[168] SA GM Act s 5(12); Tas PQ Act s 39; Tas GM Bill cl 7. Defences are provided in those two jurisdictions. See SA GM Act s 27; Tas PQ Act s 86. These are discussed below. There is no defence, though, under the Tas GM Bill.
[169] ACT GM Bill cl 9.
[170] WA GM Act s 5(2).
[171] WA GM Act s 5(3).
[172] Vic GM Act s 6(3).
[173] ACT GM Bill cls 11(2) and 12; NSW GM Act s 14(2) and (3); SA GM Act s 18(1) and (2); Tas PQ Act s 54; Tas GM Bill cls 26 and 27; Vic GM Act s 15(1); WA GM Act s 8(1) and (2).
[174] Vic GM Act s 15.
[175] ACT GM Bill cl 11(3); NSW GM Act s 14(4).
[176] ACT GM Bill cls 28(4) and 31; NSW GM Act s 33(1); Tas PQ Act s 82. Vic GM Act has no relevant provision.
[177] NSW GM Act s 16(2); Tas GM Bill cl 27(6) and cl 27(1) ‘responsible person’. Contra SA and WA where the original releaser can be responsible for such costs. See SA GM Act s 18(4); WA GM Act s 10(1).
[178] SA GM Act s s 18(5); Tas GM Bill cl 28(2); WA GM Act s 9.
[179] SA GM Act ss 18(4) and 24(1)(c); WA GM Act s 10(2) and (3).
[180] Being a substantial fine in SA, Tas, Vic and WA and fine, imprisonment or both in ACT and NSW. See ACT GM Bill cl 9; NSW GM Act s 7; SA GM Act s 5(12); Tas PQ Act s 39; Tas GM Bill cl 7; Vic GM Act s 17(2); WA GM Act s 5(1).
[181] See GT Act s 58(3). It should be noted though that the GT Act does not limit consideration of applicant’s suitability to ‘relevant convictions’. Even convictions not defined as relevant could be considered. See GT Act s 58(1).
[182] See ACT GM Bill cl 6; NSW GM Act s 3; SA GM Act Preamble; Vic GM Act s 1; WA GM Act Preamble.
[183] Tas PQ Act.
[184] Tas GM Bill Preamble and see cl 5(1).
[185] David Jones, ‘Three Year Ban on Genetically Modified Food’ (2003) 3 National Environmental Law Review 23, 23. This was in response to the ACT, Legislative Assembly, Standing Committee on Health, Inquiry into the Gene Technology Bill 2002. Report No 2 (December 2002), Recommendation 3.32.
[186] Cultivate includes ‘plant, tend, nurture or harvest the plant’. ACT GM Bill Dictionary, ‘cultivate’.
[187] That is, a food plant modified by GT or progeny of such a plant. ACT GM Bill Dictionary, ‘GM food plant’. See also ‘gene technology’ and ‘food plant’.
[188] ACT GM Bill cl 7(1).
[189] ACT GM Bill Dictionary ‘food plant’.
[190] ACT GM Bill cl 8.
[191] ACT GM Bill cl 38.
[192] ACT GM Bill cl 9. See also Criminal Code 2002 (ACT) s 20(4).
[193] ACT GM Bill cl 11(2).
[194] ACT GM Bill cl 11(3).
[195] ACT GM Bill cl 31.
[196] ACT GM Bill cl 12(1)(a).
[197] ACT GM Bill cl 11(4).
[198] Defined as in the GT Act. GMO (Environment Protection) Bill 2004 (ACT) (‘ACT EP Bill’) Dictionary ‘GMO’ and ‘genetically modified organism’.
[199] ACT EP Bill cl 7. The Bill was negatived on 1 July 2004, after completion of this article.
[200] ACT EP Bill cl 6.
[201] ACT EP Bill cl 7(1). Offences are punishable by imprisonment, fine or both. Clause 7(1).
[202] See ACT EP Bill cl 10.
[203] See ACT EP Bill cl 10(1) and (3) incorporating Gene Technology Act 2003 (ACT) s 176B.
[204] P Young, ‘States, Feds divided on GM Crops’, Australian Biotechnology News, 7 March 2003. ( <http://www.biotechnews.com.au/index.php?id=120808320 & taxid=6> accessed 7/3/03).
[205] Cultivate includes ‘plant, tend, nurture or harvest the plant’. NSW GM Act s 4(1) ‘cultivate’.
[206] NSW GM Act s 6. See also Gene Technology (New South Wales) Act 2003 (NSW) s 6(1).
[207] See NSW GM Act s 4(1) ‘GM food plant’ and s 5.
[208] NSW Government Gazette, No 119 25 July 2003, p 7513. See also NSW Government Gazette, No 198 24 December 2003, p 11686.
[209] NSW GM Act ss 6 and 43.
[210] NSW GM Act s 7. Possible penalties include imprisonment for two years, a fine or both. For corporations, see s 37.
[211] NSW GM Act s 8.
[212] NSW Government Gazette, No 119 25 July 2003 Exemption Order Number 1, 7516.
[213] NSW GM Act s 8(2). See NSW GM Act s 13 with respect to the Council.
[214] Pursuant to NSW GM Act s 14.
[215] NSW GM Act s 33(1).
[216] Pursuant to NSW GM Act s 14(4).
[217] Assented to 8 April 2004. For earlier legislative attempts in SA see Genetically Modified Material (Temporary Prohibition) Bill 2000 (SA); Gene Technology (Temporary Prohibition) Bill No 23 of 2002; Gene Technology (Temporary Prohibition) Bill No 60 of 2002.
[218] Genetically Modified Crops Management (Designation of Areas) Regulations 2004 (SA) reg 3. See The South Australian Government Gazette 22 April 2004, p 1092.
[219] SA GM Act s 5.
[220] SA GM Act s 5.
[221] SA GM Act s 3(1) ‘food crop’. A GM food crop is essentially one that is a GMO under the GT Act 2001 (SA) or its progeny. See s 3(1) ‘genetically modified food crop’, ‘genetically modified organism’ and ‘gene technology’. See also definitions of ‘livestock’ and ‘plant’.
[222] Or cultivating a GM food crop of the wrong class, as the case may be. See SA GM Act s 5(1)(b) and (c).
[223] SA GM Act s 5(12). Punishable by fine. S 5(12). For bodies corporate, see s 22.
[224] SA GM Act s 6. An exemption has been made for some releases of GM canola. See The South Australian Government Gazette 29 April 2004, pp 1123-30 Genetically Modified Crops Management Act 2004 Exemption Notice.
[225] SA GM Act s 27(2).
[226] SA GM Act s 27(3).
[227] SA GM Act s 27(3).
[228] SA GM Act s 18.
[229] SA GM Act s 18(5).
[230] SA GM Act s 18(4).
[231] SA GM Act s 24(1).
[232] SA GM Act s 29(1).
[233] (‘SA Responsibility Bill’). The Bill is in Committee in the Legislative Council.
[234] SA Responsibility Bill cl 3.
[235] SA Responsibility Bill cl 3(2).
[236] Or ensured the production of.
[237] SA Responsibility Bill cl 3(3).
[238] SA Responsibility Bill cl 3(3).
[239] There was doubt whether the early Tasmanian action was constitutionally valid. It is now largely a moot point given the passing of the Designated Areas Policy Principle. See Tranter above n 110, 257.
[240] Not defined in the legislation.
[241] Tasmanian Government Notice, Plant Quarantine, Plant Quarantine Act 1997 Section 10, Tasmanian Government Gazette, 26 July 2000, p 1164. The original notice appeared in the public notices section of State newspapers on 22 July 2000. The declaration was revoked on 10 April 2002. See Tasmanian Government Notice, Plant Quarantine, Plant Quarantine Act 1997 Section 8, Tasmanian Government Gazette, 10 April 2002, p 430.
[242] Tasmania, Department of Primary Industries, Water and Environment, Gene Technology Policy Review – Position Paper; A Balanced Approach (2003)
( <http://www.dpiwe.tas.gov.au/inter.nsf/WebPages/CPAS-5K6VRK?open> accessed 27/1/04).
[243] Pursuant to Tas PQ Act s 8. See Tasmanian Government Notice, PQ Act s 8 above n 241.
[244] Except certain already protected land.
[245] Tas PQ Act s 35. See Tasmanian Government Notice, PQ Act ss 35 and 36 Tasmanian Government Gazette, 10 April 2002, p 431.
[246] Tas PQ Act s 36. See ibid.
[247] Tas PQ Act s 39.
[248] Tas PQ Act s 86.
[249] Tas PQ Act s 54.
[250] Tas PQ Act s 78.
[251] Tas PQ Act s 82.
[252] Tasmanian Government Notice, PQ Act ss 35 and 36 above n 245.
[253] Tas PQ Act s 38.
[254] This is a policy position and not provided for in the legislation. See Tasmania, Parliamentary Debates, House of Assembly, 21 April 2004 (Kons, Minister for Primary Industries and Water).
[255] Tas, Dept of Primary Industries, Water and Environment, Gene Technology Policy Review – Position Paper; A Balanced Approach (February 2003), 4-5, 12.
[256] As at 12 May 2004, the Bill is still to be considered by the Legislative Assembly.
[257] Tas GM Bill cl 3 ‘genetically modified organism’ and ‘GMO’.
[258] Tas GM Bill cl 5(1).
[259] ‘Deal with’ has an extended meaning that includes releasing GMOs. See Tas GM Bill cl 3 ‘deal with’.
[260] With respect to permits see Tas GM Bill Part 3 Div 1.
[261] Tas GM Bill cl 7. With respect to body corporates, see cl 31.
[262] Tas GM Bill cl 9(2)(b).
[263] Tas GM Bill cl 26(b).
[264] See amendment moved by Mr Booth, Tasmania, Parliamentary Debates, House of Assembly, 22 April 2004 (Booth, Member for Bass).
[265] Or in other yet to be prescribed circumstances. Tas GM Bill cl 19(2).
[266] Tas GM Bill cl 19(4) and (5).
[267] Tas GM Bill cl 19(2).
[268] Genetic Engineering-free Zones Consultation Paper above n 14, 3.
[269] Genetic Engineering-free Zones Report above n 13, 11.
[270] Lloyd above n 29.
[271] McGrath above n 129, 36.
[272] Bob Cameron, Victorian Minster for Agriculture, Victoria Appoints Independent GM Canola Reviewer, Press Release, (26 November 2003).
[273] Lloyd above n 29, Recommendation 1, p ix.
[274] D Buttler, ‘GM canola out until 2008’, Herald Sun (Melbourne), 26 March 2004, 13.
[275] Vic GM Act s 4.
[276] Vic GM Act s 3 ‘GM crop’. See also ‘genetically modified organism’.
[277] Vic GM Act s 3 ‘plant’.
[278] Cultivate is given an extended meaning and includes to breed, germinate, propagate, grow, raise, culture, harvest or collect plants or plant material and any activity prescribed by regulations. Vic GM Act s 3 ‘cultivate’.
[279] Vic GM Act s 28 and Schedule.
[280] Vic GM Act s 17(1). The legislation also restricts dealings with GM crop related material. See s 17(1) and s 3 ‘GM crop related material’. Penalty is a fine. Vic GM Act s 17(2). Re bodies corporate, see Vic GM Act s 21.
[281] Vic GM Act s 7(1).
[282] Vic GM Act s 7(3).
[283] Vic GM Act s 15(1).
[284] Vic GM Act s 15(1).
[285] Vic GM Act s 24.
[286] Referred to in the Act as the ‘gene technology provider’. They must have made, developed, produced or manufactured the GMO. Vic GM Act s 18(1).
[287] Vic GM Act s 18(1).
[288] Gene Technology Standing Committee, Regulatory Impact Statement on Gene Technology (Recognition of Designated Areas) Principle 2003 s 5. With respect to earlier steps in WA see Genetically Modified Material (Temporary Prohibition) Bill 1999 (WA).
[289] WA GM Act s 4(1).
[290] See WA GM Act s 3 ‘genetically modified crop’. See also ‘cultivate’.
[291] Pursuant to WA GM Act s 4(2).
[292] Premier’s Department, WA, Western Australia to be “GM-free”, Press Release (22 March 2004).
[293] ‘Cultivate’ includes ‘breed, propagate, grow, raise or culture plants, or parts of plants, for that crop’. WA GM Act s 3 ‘cultivate’.
[294] WA GM Act s 5. Penalty is a fine.
[295] WA GM Act s 5(3).
[296] WA GM Act s 5(1)(d).
[297] WA GM Act s 5(2). See also s 3 ‘field trials’.
[298] WA GM Act s 10(3).
[299] WA GM Act s 8.
[300] WA GM Act s 9(1).
[301] WA GM Act s 9(2).
[302] WA GM Act s 9(3).
[303] WA GM Act s 10(2).
[304] WA GM Act s 19(1).
[305] Assuming the Tas GM Bill is enacted.
[306] There are exemptions/permits in other jurisdictions that could be relied upon in these other jurisdictions though.
[307] Assuming the Tas GM Bill is enacted.
[308] In SA, Tas (proposed), Vic and WA, there is an obligation to repay the Government the costs of destruction.
[309] See reports at n 29 above on the predicted economic effects on trade of GMO releases.
[310] See, for example, comments by the Leader of the Nationals in Victoria, Victoria, Parliamentary Debates, Legislative Assembly, 22 April 2004, 773-5 (Ryan, Leader of The Nationals) and Dr Napthine, Victoria, Parliamentary Debates, Legislative Assembly, 20 April 2004, 605-10 (Napthine, Member for South-West Coast).
[311] See, for eg, SA, Parliamentary Debates, House of Assembly, 29 March 2004 (Williams, Member for MacKillop).
[312] McGrath above n 129, 37.
[313] OGTR, Invitation to Comment on the Office of the Gene Technology Regulator’s Risk Analysis Framework (March 2004).
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