75. The following factors are taken into account when postulating relevant risk scenarios:

    • the proposed dealings, which may be to conduct experiments, develop, produce, breed, propagate, grow, import, transport or dispose of the GMOs, use the GMOs in the course of manufacture of a thing that is not the GMO, and the possession, supply and use of the GMOs in the course of any of these dealings.
    • the proposed limits
    • the proposed controls
    • characteristics of the parent organism(s)
    • routes of exposure to the GMOs, the introduced gene(s) and gene product(s)
    • potential effects of the introduced gene(s) and gene product(s) expressed in the GMOs
    • potential exposure to the introduced gene(s) and gene product(s) from other sources in the environment
    • the environment at the site(s) of release
    • agronomic management practices for the GMOs.
76. Six risk scenarios were postulated and evaluated. These are summarised in Table 2, where circumstances that share a number of common features are grouped together in broader risk categories. In the context of the control measures proposed by the applicant, and considering both the short and long term, none of the risk scenarios were identified as a risk that could be greater than negligible. Therefore, they did not warrant further detailed assessment. More detail of the evaluation of these scenarios is provided later in this section.

77. All of the introduced gene regulatory sequences, such as gene promoters, gene terminators and untranslated leader sequences, operate in the same manner as do regulatory elements endogenous to cotton plants. Any potential for adverse impacts from the introduced regulatory elements are considered equivalent to and no greater than those from endogenous regulatory elements of cotton. Therefore the potential effects will not be further assessed for this application.

78. The potential for horizontal gene transfer (HGT) and any possible adverse outcomes has been reviewed in literature (Keese 2008) as well as assessed in many previous RARMPs. HGT was most recently considered in the RARMP for DIR 108, while HGT was considered for GM cotton genetically modified for insect resistance and herbicide tolerance in DIR 101. These RARMPs are available on the website or by contacting the OGTR. No risk from HGT was identified due to the rarity of these events, and because the genes are already present in the environment and available for transfer via demonstrated natural mechanisms. This is also the case for the genes proposed for release in the GM cotton in this application so this risk category will not be assessed further.

Table 2 Summary of risk scenarios from dealings with cotton genetically modified for insect resistance and herbicide tolerance

Risk category
Risk scenario
Identified risk?
Reason
Pathway that may give rise to harmPotential harm
Section 2.1
Production of a substance toxic or allergenic to people or toxic to other organisms
1. Exposure of people or other vertebrates to GM plant material containing the proteins encoded by the introduced genes Allergic reactions in people or toxicity in people and other vertebrates No
  • The introduced genes, or homologues, and their encoded proteins are widespread in the environment and are unlikely to be toxic or allergenic to people or toxic to other vertebrates.
  • None of the GM cotton material proposed for release will be used in human food or animal feed.
  • The limited scale, and other proposed limits and controls, further reduce exposure of people and other vertebrates to products of the introduced genes.
2. Exposure of invertebrates and soil organisms to GM plant material containing the proteins encoded by the introduced genes Toxicity to non-target invertebrates or soil organisms No
  • The introduced genes, or homologues, and their encoded proteins are widespread in the environment.
  • The toxicity of the proteins encoded by the individual insect resistance genes and any combination effects are expected to be confined to target insects and a limited range of related non-target insects that are sensitive to Bt sprays.
  • The limited scale reduces exposure of invertebrates and soil organisms to the products of the introduced genes.
Section 2. 2
Weediness of GM cotton plants in the environment
3. Expression of the introduced genes increases the weediness of the GMOs Weediness; allergic reactions in people or toxicity in people and other organisms No
  • The proposed limits and controls for the release would minimise persistence of GMOs at the trial sites or dispersal of reproductive material beyond the sites.
  • Cultivated cotton is not considered to be weedy and insect resistance, herbicide tolerance and/or antibiotic resistance are unlikely to increase weediness as abiotic factors limit the spread and persistence of cotton in Australia.
Section 2. 3
Vertical transfer of genes or genetic elements to sexually compatible plants
4. Expression of the introduced genes in cotton plants that are not part of the trial Weediness; allergic reactions in people or toxicity in people and other organisms No
  • Cotton is predominately self-pollinating and outcrossing is limited.
  • The applicant proposed a number of controls, including surrounding trial fields with a 20 m pollen trap or 3 km isolation zone, which would minimise gene flow via pollen.
  • Risk scenarios 1 – 3 did not constitute risks warranting further assessment.
Section 2. 4
Unintended changes in biochemistry, physiology or ecology
5. Changes to biochemistry, physiology or ecology of the GM cotton plants resulting from expression, or random insertion, of the introduced genes Weediness; allergic reactions in people or toxicity in people and other organisms No
  • Unintended, adverse effects, if any, would be minimised by the proposed limits and controls.
  • Unexpected characteristics were not observed in the GM cotton lines produced by single transformation events in earlier trials
Section 2. 5
Unauthorised activities
6. Use of the GMOs outside the licence conditions (non-compliance) Potential adverse outcomes mentioned in Sections 2.1 to 2.4 No The Act provides for substantial penalties for non-compliance and unauthorised dealings with GMOs and also requires consideration of the suitability of the applicant to hold a licence prior to the issuing of a licence by the Regulator

2.1 Production of a substance toxic or allergenic to people or toxic to other organisms


79. Toxicity is the adverse effect(s) of exposure to a dose of a substance as a result of direct cellular or tissue injury, or through the inhibition of normal physiological processes (Felsot 2000).

80. Allergenicity is the potential of a substance, including proteins, to elicit an immunological reaction following its ingestion, dermal contact or inhalation, which may lead to tissue inflammation and organ dysfunction (Arts et al. 2006).

Risk scenario 1 Exposure of people or other vertebrates to GM plant materials containing the proteins encoded by the introduced genes

81. The proteins expressed from the introduced genes for insect resistance, herbicide tolerance and antibiotic resistance could be toxic or allergenic for people, or toxic for other vertebrates. If humans or other vertebrates were exposed to the expressed proteins in GM plant materials, this might give rise to detrimental biochemical or physiological effects on the health of these people or other vertebrates.

82. In the context of the proposed dealings, both of the following requirements would have to be met for GM cotton to have any increased toxic or allergenic effect:
    • the genetic modifications would have to result in production of toxic or allergenic proteins or compounds not present in commercially grown cotton varieties, or increased levels of toxins naturally present in cotton, and
    • humans or other vertebrates would have to be exposed to the GM cotton plants through contact, ingestion or inhalation.
83. Non-GM cotton produces natural toxins for defence against herbivory including gossypol and cycloprenoid fatty acids (OGTR 2008). The proposed genetic modifications are not expected to affect the level of these toxins produced.

84. Although no toxicity studies have been performed on plant material from the GM cotton varieties, toxicity studies have been carried out on all of the proteins encoded by the introduced genes (Chapter 1, Section 5.3) and the proteins were found to be non-toxic towards model vertebrate species. The introduced genes were isolated from naturally occurring organisms that are widespread and prevalent in the Australian environment (Chapter 1, Section 6.5), so people and animals are regularly exposed to proteins similar to those encoded by these genes. No information was found to suggest that the proteins encoded by the introduced genes are toxic or allergenic to people or toxic to other vertebrates (Chapter 1, Section 5.3).

85. FSANZ has approved food derived from all of the GM cotton lines produced by single transformation events as safe for human consumption. This approval would include products derived from stacked GM cotton varieties produced by conventional cross-breeding of these lines. There is no indication that any combination of the multiple proteins encoded by the various introduced genes would lead to an increase in the potential for toxicity or allergenicity to humans and other organisms that were unaffected by the individual proteins. Unintended effects of the proposed release are discussed in risk scenario 5.

86. The proposed limits and controls of the trial (Chapter 1, Sections 3.2 and 3.3) would minimise the likelihood of exposure of people and other vertebrates to GM plant materials. There is little potential for human ingestion of the GM cotton, as no GM plant material will be used for human food as part of this release. Similarly, livestock would not be intentionally exposed as the GM plant material will not be used as animal feed. Cotton pollen is large, sticky, and generally not dispersed by wind (OGTR 2008). The applicant proposes that access to the trial sites, and thus potential contact with or inhalation of GM plant materials, would be limited to trained and authorised staff.

87. After harvest, the applicant proposes to destroy all GM cotton materials produced, apart from some seeds and plant samples for research purposes and further plantings. These measures would minimise exposure to the GM plant material. The short duration (2012-2015) and small size (up to 36 ha per year) of the trial would also limit the potential for exposure to the GM plant material.

88. Conclusion: The potential for allergic reactions in people or toxicity in people or other vertebrates as a result of exposure to GM plant materials containing the proteins encoded by the introduced genes, in the context of the limits and controls proposed by the applicant and considering both the short and long term, is not identified as a risk that could be greater than negligible. Therefore, it does not warrant further assessment.

Risk scenario 2 Exposure of invertebrates and soil organisms to GM plant material containing the proteins encoded by the introduced genes

89. The proteins expressed from the introduced genes for insect resistance, herbicide tolerance and antibiotic resistance could be toxic for certain invertebrates or soil organisms. If non-target invertebrates or soil organisms were exposed to the expressed proteins through direct ingestion of the GM plant materials, indirect ingestion through the food chain, or contact with root exudates or dead plant material in the soil, this might give rise to detrimental biochemical or physiological effects on the health of these non-target invertebrates or soil organisms.

90. The introduced herbicide resistance genes and antibiotic resistance marker gene are isolated from organisms that are widespread in the Australian environment (Chapter 1, Section 6.5). There is no data to suggest that any of the proteins encoded by these genes are toxic to invertebrates or soil organisms.

91. The purpose of the introduced Bt genes is to provide resistance to insect herbivory. The encoded insect resistance proteins are known to be toxic to a range of insect pests of cotton, including the major Australian pest Helicoverpa armigera, as well as other target pests. The toxicity of these proteins towards insect pests that ingest cultivated cotton is not considered to be an adverse outcome but rather the intent of the genetic modification. However, non-target species such as predators of targeted pests, pollinator species and beneficial soil organisms may also be exposed to the expressed proteins.

92. Oral toxicity studies suggest that each of the individual Bt insect resistance proteins in the GMOs is non-toxic to a wide range of non-target invertebrates (Chapter 1, Section 5.3). The toxicity of the Bt insect resistance proteins is due to specific interactions with insect mid-gut receptor molecules (Chapter 1, Section 5.3). The proteins are therefore toxic only to organisms that both:
    • ingest significant doses of intact proteins, and
    • produce susceptible mid-gut receptor molecules.
93. It is possible that additive or synergistic effects could occur between the different Bt insecticidal proteins, increasing the toxic effect and/or range of insects beyond those sensitive to any one of the insect resistance proteins alone. It is not expected that the range of susceptible insects would increase beyond the insect families sensitive to the commercial Bt insecticidal sprays approved by APVMA, which contain Bt strains that express similar combinations of insect resistance proteins. Microbial Bt products have been assessed as unlikely to pose any hazard to the great majority of non-target invertebrates (International Programme on Chemical Safety 1999). However, some uncertainty exists in the area of potential additive or synergistic effects between Bt toxins isolated from different Bt strains due to data gaps.

94. Native Bt bacteria that express combinations of insect resistance proteins are widespread in the Australian agricultural and natural environments (Chapter 1, Section 6.5).

95. The short duration (2012-2015) and small size (up to 36 ha per year) of the release would limit the potential for exposure of invertebrates or soil organisms to the GM plant material.

96. Conclusion: The potential for toxicity to non-target invertebrates or soil organisms as a result of exposure to GM plant materials containing the proteins encoded by the introduced genes, in the context of the limits and controls proposed by the applicant and considering both the short and long term, is not identified as a risk that could be greater than negligible. Therefore, it does not warrant further assessment.

2.2 Weediness of the GM cotton plants in the environment


97. This section addresses the question of whether or not the proposed dealings with the GMOs may lead to harm to human health and safety or to the environment as a result of an increased potential for weediness due to the genetic modifications.

98. All plants have the potential to lead to harm in certain environments. Harms that may arise from a certain plant species in a particular environment include:
    • adverse effects on the health of people and/or animals
    • reduction in the establishment, yield and/or quality of desired plants
    • restriction in the physical movement of people, animals, vehicles, machinery and/or water
    • adverse effects on environmental health, such as adverse changes to strata levels, nutrient levels, fire regime, soil salinity, soil stability, or by providing food and/or shelter to pests, pathogens and/or diseases (National Weed Prioritisation Working Group 2006).
99. For the purpose of this document, plant species causing significant levels of one or more of these harms are called ‘weeds’. A plant species may be weedy in one or more land uses, such as dryland cropping or nature conservation.

100. Characteristics that influence the spread (dispersal of the plant or its genetic material) and persistence (establishment, survival and reproduction) of a plant species impact on the degree of its invasiveness. These characteristics include the ability to establish in competition with other plants, to tolerate standard weed management practices, to reproduce quickly, prolifically and asexually as well as sexually, and to be dispersed over long distances by natural and/or human means (National Weed Prioritisation Working Group 2006). The degree of invasiveness of a plant species in a particular environment gives an indication of the likelihood of its weediness in that environment. In addition to local experience, a history of weediness overseas can be used as an indicator for weediness in Australia (Pheloung et al. 1999).

101. Baseline information on the potential weediness of non-GM cotton plants is given in The Biology of Gossypium hirsutum L. and Gossypium barbadense L. (cotton) (OGTR 2008). In summary, cotton does not possess any of the characteristics associated with problematic weeds, and the spread and persistence of cotton are limited by a number of biotic and abiotic factors, especially cold stress in southern Australia and water stress in non-irrigated environments throughout almost all of Australia. Cotton has been grown for centuries throughout the world without any reports that it is a serious weed, and it is likewise not considered to be a serious weed in Australia (Groves et al. 2003).

Risk scenario 3 Expression of the introduced genes increases the weediness of the GMOs

102. In the context of the proposed dealings, in order for the GM cotton plants to become weedy in the environment both of the following conditions would need to be met:
    • GM cotton plants are present outside the limits (locations and/or duration) of the trial; and
    • GM cotton plants are able to establish populations that cause harms associated with weediness.
Presence of GM cotton plants outside the trial limits

103. GM cotton plants could be present outside the trial limits due to survival at the trial sites after completion of the trial duration, or due to dispersal of reproductive plant material outside the site locations during or after the trial.

104. After completion of the trial, it is possible that whole GM plants could survive in the trial sites, or ratoon plants could regrow from post-harvest stubble, or new volunteer plants could grow from seeds fallen in the trial fields. The applicant proposes a number of control measures to prevent these eventualities, including: destruction of all plant materials not required for further analysis or future planting, cultivating field planting sites after harvest to encourage decomposition or germination of remaining seed, post harvest monitoring of each trial site for at least twelve months and until the site has been clear of volunteers for six months, and to destroy any volunteers found prior to flowering. It is not expected that genetic modifications for the traits of insect resistance, herbicide tolerance or antibiotic resistance would increase the ability of the GMOs to survive these standard control measures.

105. Potential dispersal of reproductive GM plant material outside the site boundaries would be limited to seed or pollen, as cotton does not reproduce vegetatively under natural conditions (OGTR 2008). Gene flow via pollen is discussed in risk scenario 4. As the introduced genes of the GMOs are not related to seed production and dispersal traits, these characteristics are not expected to be altered in the varieties of GM cotton proposed for release compared to non-GM or commercially released GM cotton varieties.

106. In the field, seed cotton is present as large lint-covered bolls. Wild mammals and birds generally avoid feeding on cotton plants, in particular finding the seed unpalatable because of its high gossypol content, and therefore wild animals do not disperse bolls any great distance from the cotton fields (OGTR 2008). GM cotton seeds produced in this trial will not be used as stock feed, so would not be dispersed by stock.

107. Cotton bolls are large, heavy and remain attached to the plant (OGTR 2008), so they are not normally transported by wind or by runoff after rainfall or irrigation. Extremes of weather may cause dispersal of plant parts. The applicant proposes that release sites will be located at least 50 m away from natural waterways to prevent dispersal in the event of flooding.

108. Dispersal of seeds by authorised people entering the trial sites would be minimised by cleaning of all equipment used at the trial sites, including clothing. The applicant proposes to transport any plant material according to the Regulator’s transport guidelines. Spillage of GM seed during transport to and from the release sites would be rare and could be readily controlled through cleaning and monitoring of the site of the spill.

GM cotton plants are able to establish populations that cause harms associated with weediness

109. Non-GM or commercially released GM cotton seed is abundant in the environment through distribution pathways including residual seed bank in growing fields, roadside seed spills and dispersal through use as stock feed. Despite this, feral cotton populations are sparse and ephemeral (OGTR 2008) in all current cotton growing regions of Australia. The only regions of Australia in which small naturalised cotton populations are known to have established are disturbed areas of the wet tropics of northern Australia. Modelling of climactic factors limiting cotton persistence indicate that cotton has naturalisation potential only in the coastal regions of north-east Australia (Rogers et al. 2007), which are over two hundred kilometres away from any of the proposed trial sites.

110. The expression of the introduced genes for insect resistance, herbicide tolerance, or antibiotic resistance traits are not expected to increase cotton survival in unfavourable climactic conditions such as cold stress or dry stress. In the unlikely event that GM cotton plants were present outside the trial limits, their ability to spread and persist would be restricted in the same way as non-GM cotton plants. Cotton persistence is expected to be limited by cold stress for the proposed field trial sites in Narrabri LGA, and limited by water availability in all three of the proposed LGAs. Small and ephemeral feral GM cotton populations would be unlikely to cause harms associated with weediness such as reducing establishment of desired plants, restricting physical movement, or adversely affecting environmental health.

111. Even small and ephemeral feral GM cotton populations could cause adverse effects to human or animal health through toxicity. However, toxicity of the introduced proteins of the GMOs was discussed in risk scenarios 1 and 2. It is unlikely that the GMOs would have higher toxicity than non-GM cotton, except towards a limited range of insects, many of which are agricultural pests.

112. Conclusion: The potential for harm due to expression of the introduced genes increasing the weediness of the GMOs, in the context of the limits and controls proposed by the applicant and considering both the short and long term, is not identified as a risk that could be greater than negligible. Therefore, it does not warrant further assessment.

2.3 Vertical transfer of genes or genetic elements to sexually compatible plants


113. Vertical gene flow is the transfer of genetic information from an individual organism to its progeny by conventional heredity mechanisms, both asexual and sexual. In flowering plants, pollen dispersal is the main mode of gene flow (Waines & Hegde 2003). For GM crops, vertical gene flow could therefore occur via successful cross-pollination between the crop and neighbouring crops, plants, related weeds or native plants (Glover 2002).

114. It should be noted that vertical gene flow per se is not considered an adverse outcome, but may be a link in a chain of events that may lead to an adverse outcome. For an increased potential for adverse effects to arise as a result of gene flow of the introduced genetic elements from the GM cotton varieties to sexually compatible plants, both of the following steps must occur:
    • transfer of the introduced genetic elements to sexually compatible plants
    • increased potential for adverse effects, such as allergenicity, toxicity or weediness of the recipient plants, due to expression of the introduced gene(s).
115. Baseline information on vertical gene transfer associated with non-GM cotton plants is provided in The Biology of Gossypium hirsutum L. and Gossypium barbadense L. (cotton) (OGTR 2008). In summary, cotton is predominantly self-pollinating and outcrossing is rare, although cross-pollination can occur at low levels over short distances. The only sexually compatible species present in Australia that could receive genes from the GM cotton are G. hirsutum and G. barbadense (including both cultivated GM and non-GM cotton, and naturalised cotton).

116. Most of the Australian Gossypium species have limited distributions and occur at considerable geographic distances from cultivated cotton fields. Furthermore, there is well established genetic incompatibility between native Gossypium species and cultivated cotton; the likelihood of fertile hybrids occurring between cultivated cotton and native Gossypium species is very low (summarised in OGTR 2008). Therefore, these species are not considered further.

Risk scenario 4 Expression of the introduced genes in cotton plants that are not part of the trial

117. If the introduced genes for insect resistance, herbicide tolerance or antibiotic resistance were transferred and expressed in cotton plants that are not part of the trial, the resulting plants could have increased toxicity or allergenicity to people, toxicity to other organisms, or weediness potential.

118. Pollen dispersal characteristics are not expected to be altered in the varieties of GM cotton proposed for release compared to non-GM or commercially released GM cotton varieties. As discussed in the The Biology of Gossypium hirsutum L. and Gossypium barbadense L. (cotton) (OGTR 2008) cotton is predominantly self-pollinating, with pollen that is large, sticky and heavy and generally not dispersed by wind. Cotton gene flow studies consistently show that outcrossing is localised around the pollen source and decreases rapidly with distance.

119. The applicant has proposed a number of measures to restrict the potential for gene transfer via pollen flow to sexually compatible plants (Chapter 1, Section 3.2 and 3.3). These include surrounding the trial sites with either a 20 m pollen trap or a 3 km exclusion zone (within which intentional planting of cotton is not allowed). Either of these measures is expected to prevent transport of pollen to nearby cotton crops by pollinators during the course of the trial. Provisions are made to monitor for volunteer cotton plants and to destroy any volunteers prior to flowering. Limits on the number of sites (up to 6 per year) and duration (3 years) of the trial would further reduce the likelihood of vertical gene transfer occurring.

120. As discussed in risk scenarios 1 and 2, the proteins encoded by the introduced genes are unlikely to be allergenic to people or toxic to people or organisms, except for toxicity towards certain target invertebrates and toxicity to a limited range of related non-target invertebrates. As discussed in risk scenario 3, the proteins encoded by the introduced genes are unlikely to increase weediness, as the spread and persistence of cotton plants is primarily limited by abiotic factors. These risk assessments would not change if the introduced genes were expressed in cotton plants that are not part of the trial.

121. Previously approved commercial GM cotton varieties (Section 7.1.1) may be planted in the vicinity of the trial sites. If crossing occurred between the GM cotton varieties proposed for release and some of the commercial GM cotton varieties which express different Bt insecticidal proteins, this could result in cotton plants containing a new combination of stacked insect resistance genes. This could potentially increase the toxic effect and/or range of susceptible insects relative to either of the individual parent GM plants and is an area of uncertainty due to data gaps.

122. If a pollen trap is used to control pollen flow in the proposed trial, the cotton plants in the pollen trap may be non-GM cotton or GM cotton approved under commercial licences DIR 062/2005 or DIR 066/2006. Additional discussion of potential stacking of introduced genes by cross-pollination between the GMOs and pollen trap plants is covered by CCI. The confidential information was made available to the prescribed experts and agencies that were consulted on the RARMP for this application. The applicant proposes that pollen trap plants will be handled, controlled and monitored post-harvest in the same way as the GMOs.

123. Conclusion: The potential for increased allergenicity in people, toxicity in people and other organisms, or increased weediness due to the expression of the introduced genes in cotton plants that are not part of the trial as a result of gene transfer, in the context of the limits and controls proposed by the applicant and considering both the short and long term, is not identified as a risk that could be greater than negligible. Therefore, it does not warrant further assessment.

2.4 Unintended changes in biochemistry, physiology or ecology


124. All methods of plant breeding can induce unanticipated changes in plants (Haslberger 2003). Gene technology has the potential to cause unintended effects that may include:
    • producing a gene product that affects multiple traits
    • altered expression of an unrelated gene at the site of insertion of new genetic material
    • altered expression of an unrelated gene distant to the site of insertion, for example, due to the encoded protein of an introduced gene changing chromatin structure, affecting methylation patterns, or modulating signal transduction and transcription
    • increased metabolic burden associated with high level expression of an introduced gene
    • novel traits arising from interactions of the protein encoded by an introduced gene product with endogenous non-target molecules
    • secondary effects arising from altered substrate or product levels in a biochemical pathway incorporating the protein encoded by an introduced gene.
Risk scenario 5 Changes to biochemistry, physiology or ecology of the GM cotton plants resulting from expression or random insertion of the introduced genes

125. Unintended pleiotropic (collateral) effects of the genes introduced into the GM cotton varieties might result in adverse outcomes such as production of novel toxins or allergens or higher levels of endogenous toxins or allergens; increased weediness; altered pest or disease burden; or reduced nutritional value as compared to the parent organism.

126. The outcome of random insertion of introduced genes is impossible to predict. However, unintended changes that occur as a result of gene insertions are rarely advantageous to the organism (Kurland et al. 2003), so are unlikely to increase spread or persistence of the GM plants.

127. Accumulated experience with genetic modification of plants indicates that, as for conventional (non-GM) breeding programs, the process has little potential for unexpected outcomes that are not detected and eliminated during the early stage of selecting plants with new properties (Bradford et al. 2005). The applicant states that large numbers of GM breeding lines have been tested for the desired agronomic and GM traits and only the best performing lines were selected for further development. The GM cotton lines produced by single transformation events have been extensively tested in field trials, in Australia and other countries, and no unintended secondary effects have been observed.

128. The applicant proposes to measure the agronomic performance of the stacked GM cotton varieties during this limited and controlled release, and any unintended effects resulting in agronomic penalties are likely to be detected during the trial. The biochemical composition (levels of toxins and nutrients) of the GM cotton plant material, particularly the stacked GMOs, is an area of uncertainty due to data gaps.

129. Adverse effects, if any, arising due to inadvertent changes in biochemistry, physiology or ecology will be minimised by the proposed limits and controls outlined in Chapter 1, Sections 3.2 and 3.3. In particular, the small scale and short duration of the trial would limit the potential for adverse effects. Humans and livestock would not be intentionally exposed to the GM plant material as the GM cotton will not be used as food or animal feed as part of the release.

130. Conclusion: The potential for an adverse outcome as a result of inadvertent changes in biochemistry, physiology or ecology is not identified as a risk that could be greater than negligible. Therefore, it does not warrant further assessment.

2.5 Unauthorised activities


Risk scenario 6 Use of the GMOs outside the licence conditions (non-compliance)

131. Non-compliance with the conditions imposed by the licence could lead to spread and persistence of the GM cotton plants outside of the release areas and/or increased exposure of people and other organisms to GM material. The adverse outcomes that this risk scenario could cause are the same as those discussed in the sections above. The Act provides for substantial penalties for non-compliance and unauthorised dealings with GMOs. The Act also requires that the Regulator has regard for the suitability of the applicant to hold a licence prior to the issuing of a licence. These legislative provisions are considered sufficient to minimise risks from unauthorised activities.

132. Conclusion: The potential for an adverse outcome as a result of unauthorised activities is not identified as a risk that could be greater than negligible. Therefore, it does not warrant further assessment.