Dir 128 Full Risk Assessment and Risk Management Plan (rarmp)
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- Bu səhifədəki naviqasiya:
- Risk source
- Risk management
- Risk treatment measures for identified risks
- Licence conditions to limit and control the release
- Summary of licence conditions to be implemented to limit and control the release
- Other risk management considerations
- Identification of the persons or classes of persons covered by the licence
- Monitoring for Compliance
- Issues to be addressed for future releases
- Conclusions of the RARMP
| Conclusion: Risk scenario 1 is not identified as a substantive risk, due to the likely limited exposure of humans to the expressed proteins, and the predicted lack of significant toxicity or allergenicity of the introduced proteins to humans and other organisms. Therefore, this risk could not be greater than negligible and does not warrant further detailed assessment.
Risk scenario 2
Risk source The source of potential harm for this postulated risk scenario is the introduced abiotic stress tolerance and micronutrient genes. Causal pathway The abiotic stress tolerance and micronutrient genes are present in plant tissues. If seed was dispersed outside any of the trial sites, this seed could germinate and give rise to plants expressing the introduced genes. These plants could spread and persist in the environment outside the trial limits and people and other organisms may be exposed to GM plant materials. Dispersal of GM plant material outside the limits of any trial site could occur through the activity of people (including the use of agricultural equipment), the activity of animals such as rodents, herbivores and birds, or through extremes of weather such as flooding or high winds. Wheat and barley lack seed dispersal characteristics such as stickiness, burrs and hooks, which can contribute to seed dispersal via animal fur (Howe & Smallwood 1982). The intended introduced traits of the GM plants, abiotic stress tolerance and micronutrient uptake, are not expected to alter these characteristics of seeds. Seed dispersal for wheat and barley through endozoochory (the ingestion and excretion of viable seeds) has not been reported. Nevertheless, it cannot entirely be discounted that wheat and barley seeds could be dispersed and germinate after passage through the digestive system of some mammals or birds. For example, viable wheat seeds have been detected in cattle dung (Kaiser 1999). Seeds which survive chewing and digestion by animals are typically small and dormant (Malo & Suárez 1995). Corellas were shown to excrete some viable wheat seeds, although the proportion is extremely low (Woodgate et al. 2011). Kangaroos, rabbits and rodents are known pests of wheat and barley crops, and cattle or sheep may graze cereals. Each site will be fenced, limiting the possibility of seed dispersal by any large animals such as cattle and sheep. Rabbits favour soft, green, lush grass (Myers & Poole 1963) and select the most succulent and nutritious plants first (Croft et al. 2002). Although viable seeds from a variety of plant species have been found in rabbit dung, viable wheat seeds were not among them (Malo & Suárez 1995). Barley seeds were not recorded in this study. Other studies have shown that generally very few viable seed are obtained from rabbit dung (Welch 1985; Wicklow & Zak 1983). Rodents are opportunistic feeders and their diets include seeds and other plant material (Caughley et al. 1998). They may not only eat and destroy seed at the seed source but also hoard seeds (AGRI-FACTS 2002), which increases the possibility of seed dispersal. Similar to other licences issued for field trial of GM plants including wheat and barley, the applicant is proposing a 10 m monitoring zone around the GM planting area to be maintained in a manner that does not attract or harbour rodents (such as keeping it bare or mown) and implementation of rodent control measures if rodents are detected. Only a very limited amount of rodent activity has been observed at trial sites under these other GM field trial licences. These standard measures minimise the potential for seed dispersal by rodents. Characteristics that influence the spread (dispersal of the plant or its genetic material) and persistence (establishment, survival and reproduction) of a plant species determine 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. Baseline information on the weediness of wheat and barley, including factors limiting the spread and persistence of non-GM plants of these species, is given in The Biology of Triticum aestivum L. em Thell (Bread Wheat) (OGTR 2008b) and The Biology of Hordeum vulgare L. (barley) (OGTR 2008a). In summary, both wheat and barley have some characteristics of invasive plants, such as being capable of wind-pollination (although wheat is predominantly self-pollinating) and the ability to germinate or to produce seed in a range of environmental conditions. However, these cereals lack most of the characteristics that are common to invasive plants, such as the ability to produce a persisting seed bank, rapid growth to flowering, continuous seed production as long as growing conditions permit, high seed output, high seed dispersal and long-distance seed dispersal (Keeler 1989). In addition, both cereals have been bred to avoid seed shattering, and white wheat cultivars have little seed dormancy (OGTR 2008a; OGTR 2008b).
The techniques of conventional breeding (eg selection of plants amongst available germplasm, wide crosses, mutagenesis) have been used to produce varieties of wheat and barley that possess various abiotic stress tolerances. The experience of conventional breeding is a useful backdrop against which to view the potential invasiveness of the abiotic stress tolerant GM plants in this application. Crosses with wild relatives have been used to transfer useful genes to crop plants (Goodman et al. 1987; Hajjar & Hodgkin 2007; Maxted & Kell 2009; Prescott-Allen & Prescott-Allen 1998). Wheat is a crop where such transfer has been most fruitful. Wild relatives of wheat that have been exploited as sources of genes include a whole range of Aegilops species (eg Ae. tauschii, Ae. speltoides, Ae. squarrosa), Triticum species (eg T. turgidum subsp. dicoccoides and T. monococcum) and Thinopyrum bessarabicum. Although the transfer of genes conferring disease and pest resistance has been most common, a survey of published reports of the use of wild relatives in breeding found that 13% concerned abiotic stress tolerance (Maxted & Kell 2009). Mutagenesis has also been used to generate a number of varieties of cereals (and many other crops) that have abiotic stress tolerances (Ahloowalia et al. 2004; Cheema et al. 1999; Tomlekova 2010)( http://mvgs.iaea.org/). With respect to its progenitor, the gamma radiation induced barley variety Golden Promise has been shown to possess both enhanced drought and salt tolerances (Forster 2001). Aluminium tolerant lines of barley have been identified amongst four varieties of barley exposed to chemical mutagenesis (Nawrot et al. 2001). Importantly, no abiotic stress tolerant wheat or barley plant that has been generated by any form of conventional breeding has been demonstrated to have increased invasiveness, and the introduced genes are not expected to increase the potential invasiveness of GM plants relative to non-GM plants subjected to conventional breeding. De-domestication, the evolutionary loss of traits gained under domestication, is frequently found amongst the small number of known examples of the evolution of invasiveness amongst existing crop plants, this being most obviously reflected in the acquisition of the ability to more readily disperse seed or fruits (Ellstrand et al. 2010). The only known case of invasiveness in wheat is in Tibet, where ‘semi-wild’ wheat (presumably the result of de-domestication) has shattering heads (brittle rachis) and hulled seeds (toughened glumes preventing free threshing) (Ayal & Levy 2005). Both these traits are absent from domesticated wheat, underlining their importance in marking the boundary between cultivated and weedy forms of this plant; shattering allows easy seed dispersal in the wild, while the hull around grains protects the grain from abiotic and biotic stresses. Although the de-domestication of barley has not been recorded, compared to its wild progenitor, domesticated barley possesses a non-brittle rachis, with some modern varieties being hulled and some hull-less, the latter being preferred for human food due to the ease to isolate grain (Azhaguvel & Komatsuda 2007; Taketa et al. 2008). However, there is no reason to believe that the introduction of the genes into wheat and barley is likely to lead to a reversion of either the non-shattering or hull-less traits. The obvious rarity of the natural loss of the non-shattering and hull-less traits in conventionally bred commercial wheat and barley varieties indicate their genetic stability. Further, none of the introduced genes are amongst those known to be associated with shattering or the toughness of the glumes (Sang 2009).
The proposed limits and controls of the trial would minimise the likelihood of spread and persistence of the GM plants. The small size (up to 2.5 ha per year) will limit the potential for dispersal of GM plant material and exposure to this material. Each of the proposed trial sites will be surrounded by a fence and only approved staff with appropriate training will have access to these sites, which will minimise potential for dispersal of seed by grazing livestock and people. This will reduce inadvertent access by humans and prevent grazing livestock from entering any site, thus minimising dispersal of GM plant material and exposure to this material. Dispersal of GM plant material by authorised people entering the proposed trial site would be minimised by a standard condition of DIR licences which requires the cleaning of all equipment used at the trial site, including clothing. All GM plant material will be transported in accordance with the Regulator’s transport guidelines, which will minimise the opportunity for its dispersal. Limits and controls are further discussed in Chapter 3. Furthermore, extra conditions associated with growing the GM plants in the NGNE facilities would also reduce the likelihood of plant material being mixed between different GM trials conducted concurrently in these facilities and subsequently spread. Potential harm As discussed in Section 2.3 of this Chapter, 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, animals or the environment, reducing establishment, yield and/or quality of desired plants, and restricting physical movement. As discussed in risk scenario 1, the introduced gene products are not expected to be toxic or allergenic to people, or toxic to other organisms. This would apply even if the GM wheat and barley plants established beyond the trial limits. However, GM wheat and barley plants established beyond the trial limits could potentially impact the environment by reducing the establishment of desired plants. In turn, this could lead to the fragmentation of the habitats of other plants, decreasing the probability of these plants (and the animals that live amongst these plants) maintaining effective breeding populations. As such, there may be a reduction in the biodiversity in regions where the GM plants grew. In reference to native habitats, it must nevertheless be appreciated that there would have to be large numbers of GM plants before the establishment of native plants was affected. In particular, if GM wheat and barley lose the trait of non-shattering heads, they would be expected to spread and persist to a greater degree than that of non-GM commercial varieties of these species, their grain being naturally lost and less dependant on human intervention for dispersal. Such GM plants would likely reduce the number of domesticated plants growing successfully to maturity and setting seed in fields, hence reducing the yield of these cereals. This is an essential facet of the problem with Ae. cylindrica in the United States, where the heads of this plant typically shatter prior to wheat harvest, generating a seed bank in the soil that persistently gives rise to these plants amongst the desired cereals (Colquhoun & Fandrich 2003; Yenish et al. 2009). In the case of wheat, prior to late maturity, it could possibly be difficult, if not impossible, to distinguish between shattering and non-shattering varieties. The potential of these harms can be evaluated against the experience of conventional breeding. No commercially released variety of wheat or barley that is the product of any form of conventional breeding has been recorded to have negatively impacted the environment (or the health of humans and/or animals), beyond that normally associated with these cereals, and subsequently flagged as an environmental weed. In this context, it is especially relevant to remember, as noted above, that a number of these conventional varieties have been bred for abiotic stress tolerance, and none have been recorded as causing harms to the environment. Therefore, the introduction into wheat and barley of any of the genes that are the subject of this application is unlikely to result in the GM plants possessing a trait that leads them to being classified as a weed (National Research Council 1989).
Risk source The source of potential harm for this postulated risk scenario is the introduced abiotic stress tolerance and micronutrient genes. Causal pathway The abiotic stress tolerance and micronutrient genes are present in plant tissues. Pollen from the GM plants could be transferred outside of a trial site (eg via wind) and fertilise sexually compatible plants, whether they be non-GM wheat or barley, or plants from another species. Alternatively, if seed was dispersed outside any of the trial sites, plants expressing the introduced genes may grow and subsequently disperse pollen. Hybrid plants possessing the introduced genes may form the basis for the spread of these genes in other varieties of wheat or barley, or other plant sexually compatible species. People and other organisms could be exposed to the proteins expressed from the introduced genes through contact with (including inhalation of pollen) or consumption of GM plant material deriving from the plants to which the genes have been transferred. Baseline information on vertical gene transfer associated with non-GM wheat and barley plants can be found in The Biology of Triticum aestivum L. em Thell (Bread Wheat) (OGTR 2008b) and The Biology of Hordeum vulgare L. (barley) (OGTR 2008a). 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. The proposed limits and controls of the trial (discussed in risk scenarios 1 and 2) would minimise the likelihood of the dispersal of pollen, seed and exposure to GM plant material. Wheat plants and barley plants are predominantly self-pollinating and the chances of natural hybridisation occurring with commercial crops or other sexually compatible plants are low and decreases with distance to the GM plants. Outcrossing rates decline significantly over distance, with most pollen falling within the first few metres. Rates are also influenced by the genotype of the variety, and environmental conditions, such as wind direction and humidity. Wheat is sexually compatible with many species within the genus Triticum, and in closely related genera such as Aegilops, Secale (rye) and Elytrigia (Chapter 1, Section 6.3). Durum wheat (other than bread wheat, the only Triticum species present in Australia) can cross with wheat, although there are no reports of gene flow beyond 40 m (Matus-Cadiz et al. 2004). Hybrids between wheat and Secale cereale are sterile, but treatment with colchicine doubles the chromosome number and results in a fertile plant, the commercialised Triticale (Knupffer 2009). Natural hybridisation between wheat and Triticale rarely occurs (Ammar et al. 2004; Kavanagh et al. 2010), at least partly due to both species being largely self-fertilising (Acquaah 2007). Elytrigia repens does occur as an introduced plant in Australia, but a review of possible means of pollen-mediated gene flow from GM wheat to wild relatives in Europe concluded that there was a minimal possibility of gene flow from wheat to Elytrigia spp. (Eastham & Sweet 2002). Species of Aegilops are not known in Australia. Although specific data is lacking, it is likely that hybridisation of wheat and barley with the four native Australasian Triticeae genera never occurs under natural conditions. Limitations on hybridisation between H. vulgare and plants from the secondary and tertiary gene pools implies there is negligible risk of gene transfer from the GM barley plants to these relatives (OGTR 2008a). The applicant proposes to control related species within a 10 m monitoring zone around the trial site and to prevent cultivation of other wheat, barley and sexual compatible plant species within 200 m of the trial site. Isolation from related species and other wheat and barley cultivation will greatly restrict the potential for pollen flow and gene transfer. In addition, the applicant proposes to perform post-harvest monitoring and to destroy any volunteer plants found at the site to ensure that no GM wheat and barley remain that could then hybridise with sexually compatible plants. Potential harm People who are exposed to the proteins expressed from the introduced genes or their associated products through contact or consumption of GM plant material may show toxic or allergenic reactions, while organisms may show toxic reactions from consumption of GM plant material. In the rare event of vertical transfer of the introduced genetic material from the GM plants to non-GM wheat and barley plants or sexually compatible species, the genetic material is expected to behave in similar ways as in the GM wheat and barley. As discussed in risk scenario 1, the introduced gene products are not expected to be toxic or allergenic to people, or toxic to other organisms and there is no reason to expect the production of an associated compound with a toxic or allergenic property. The traits that have been engineered into the GM plants of this application could become, via vertical gene transfer, combined with traits possessed by other non-GM commercially cultivated wheat and barley plants. However, as discussed above (risk scenario 1), plants that are the product of hybridisation between two varieties are unlikely to possess a level of toxicity or allergenicity greater than that of either parent. Conclusion: Risk scenario 3 is not identified as a substantive risk, due to the predicted lack of toxicity or allergenicity of the introduced proteins to humans or other organisms, there being no reasonable expectation that toxicity or allergenicity will be a problem in any plants that are the products of the GM plants and other plants, and the nature of the limits and controls proposed for the field trial to restrict gene flow. Therefore, this risk could not be greater than negligible and does not warrant further detailed assessment. Risk scenario 4
Risk source The source of potential harm for this postulated risk scenario is the introduced abiotic stress tolerance and micronutrient genes. Causal pathway The abiotic stress tolerance and micronutrient genes are present in plant tissues including pollen. Pollen from the GM plants could be transferred outside of a trial site (eg via wind) and fertilise sexually compatible plants, whether they be non-GM wheat or barley, or plants from another species. Alternatively, if seed was dispersed outside any of the trial sites, plants expressing the introduced genes may grow and disperse pollen. Hybrid plants possessing the introduced genes may form the basis for the spread of these genes in other (initially non-GM) varieties of wheat or barley, or other plant species. These plants could persist in the environment, displacing other, desirable plants. The proposed limits and controls of the trial (discussed in risk scenarios 1 and 2) would minimise the likelihood of the dispersal of pollen and seed. Vertical transfer was reviewed in risk scenario 3. The proposed limits and controls of the trial would minimise the possibility that seed would leave any trial site, or that pollination would occur to plants outside a trial site. Wheat and barley are predominantly self-pollinating, but are capable of crossing with a number of plant species that exist in Australia.
If the vertical transfer of the introduced genes from the GM plants causes the recipient species to spread and persist in the environment to a degree greater than normally found amongst these species, they may produce one or more harms. These potential harms were summarised in risk scenario 2. In particular, the GM plants may act to reduce the establishment and yield of desired plants and subsequently reduce biodiversity. Risk scenario 2 summarises the reasons that the introduced genes are unlikely to make the GM wheat and barley lines more weedy, particularly as they are not associated with the key weediness traits of shattering heads and hulled seeds, although there is some uncertainty about whether the traits could potentially improve the persistence of the GM plants outside of the agricultural setting.These reasons are likely to be applicable to any plants to which the genes are transferred. The traits that have been engineered into the GM plants of this application could become, via vertical gene transfer, combined with traits possessed by other non-GM commercially cultivated wheat and barley plants. However, as discussed above (risk scenario 2), plants that are the product of hybridisation between two varieties are unlikely to possess a level of weediness greater than that of either parent. Conclusion: Risk scenario 4 is not identified as a substantive risk, as the introduced genes are unlikely to lead to increased weediness in the GM plants themselves or any other plants to which they are transfered, and because of the nature of the limits and controls proposed for the field trial. Therefore, this risk could not be greater than negligible and does not warrant further detailed assessment. Risk scenario 5
Risk source The source of potential harm for this postulated risk scenario is the introduced abiotic stress tolerance and micronutrient genes. Causal pathway The abiotic stress tolerance and micronutrient genes are present in plant tissues. The NGNE facility is a multiuser facility, where at any one time, more than one licence holder may be conducting trials of different GM plants. Pollen from the GM plants of one trial could inadvertently fertilise other sexually compatible GM plants, including volunteers, inside a site. This pollen could be the result of transfer by an agent (eg wind, insects) from one planting area to another, or derived from volunteer plants from either trial. In early 2014, the only licence that is authorised to trial sexually compatible GM plants in either of these facilities is DIR 112, a licence held by CSIRO for the growth of GM wheat and barley with altered grain composition or nutrient utilisation efficiency (abiotic stress tolerance) at Merredin. DIR 099, also held by the CSIRO, authorises the growth of GM plants with the same traits as DIR 112 at Merredin, but the period for plantings has finished and there has been no application for an extension of time. In the case of the non-NGNE sites, all three sites have been previously used for field trials of GM plants under DIR 102, volunteers of which could still arise and hybridise with the plants of this application. Currently, DIR 102 authorises the growth of GM wheat and barley at the three non-NGNE sites of this application until December 2015. The traits of the DIR 102 plants are classified as abiotic stress tolerances and some of the genes are identical to the genes in this application. As volunteer numbers from DIR 102 are expected to be low, stacking between volunteers from DIR 102 and DIR 128 is less likely to occur than stacking between GM plants from DIR 128. Even if unintentional stacking did occur, it would still result in plants with abiotic stress tolerance. People working with any trial could be exposed to the hybrid plants. Vertical gene transfer associated with non-GM wheat and barley plants was discussed in risk scenario 3. In summary, these two cereals are predominantly self-pollinating, but are capable of crossing with a number of plant species that exist in Australia. The applicant proposes to surround each planting area in any trial site by a 2 m wide buffer zone where plant growth will be controlled by mowing, herbicide treatment and/or weeding. Further, the applicant has requested permission to grow GM wheat and barley from different licences next to each other providing they are separated by buffer zones of at least 4 m. The RARMP for DIR 094 considered the possibility of hybidisation occurring over these distances, and concluded that it would be minimal. The licence for DIR 112 specifies that if the GM plants of that trial are grown in the Merredin NGNE facility at the same time as sexually compatible GM and non-GM plants from another licence, seed from any plants of DIR 112 must not be used for the development of commercial cultivars. Such a measure would help minimise the likelihood that the genes of this application would be spread to other plants and being inadvertently grown outside a trial site, leading to people being inadvertently exposed to GM material. The proposed limits and controls of the trial would minimise the possibility that seed would leave any trial site. These are discussed under risk scenario 2. Therefore exposure would be restricted to people working at the trial sites. All GM seed leaving trial sites will be transported in accordance with the Regulator’s transport guidelines, which will minimise the opportunity for its dispersal and exposure of other people.
People who are exposed to the proteins expressed from the introduced genes or their associated products through contact or consumption of GM plant material may show toxic or allergenic reactions, while organisms may show toxic reactions from consumption of GM plant material. As discussed in risk scenario 1, the introduced gene products of this application are not expected to be toxic or allergenic to people, or toxic to other organisms and there is no reason to expect the production of an associated compound with a toxic or allergenic property. The toxicity and allergenicity associated with the introduced genes of other sexually compatible GM plants growing in a NGNE facility would be the subject of the RARMP(s) associated with their licence(s). According to the RARMPs for DIR 099, 102 and 112, there is no information to suggest that the proteins encoded by the introduced genes of those applications are likely to be toxic to people or other organisms, or allergenic to people. As discussed above (risk scenario 1), plants that are the product of hybridisation between two GM varieties are unlikely to possess a level of toxicity or allergenicity greater than that of either parent (ie the stacking of genes from different GM plants will be unlikely to generate a plant with a higher level of toxicity or allergenicity than the individual GM parents).
Risk source The source of potential harm for this postulated risk scenario is the introduced abiotic stress tolerance and micronutrient genes. Causal pathway The abiotic stress tolerance and micronutrient genes are present in plant tissues. As discussed in Risk Scenario 5, the NGNE facility is a multiuser facility, where at any one time, more than one licence holder may be conducting trials of different GM plants. Pollen from the GM plants of one trial could inadvertently fertilise other sexually compatible GM plants, including volunteers, inside a site. GM wheat and barley plants with altered grain composition or nutrient utilisation efficiency (abiotic stress tolerance) from DIR 112 and 099 may be present at Merredin. Additionally, the non-NGNE sites may have GM wheat and barley plants or volunteers with abiotic stress tolerances from the DIR 102 field trial. If hybridisation occurred between the GM plants of this application and those of DIR 112, 102 or 099, the progeny would have the traits of abiotic stress tolerance or micronutrient uptake stacked with additional abiotic stress tolerances, altered grain composition or altered nutrient utilisation efficiency. If plant material, which unknowingly was the product of hybridisation between the GM plants of this trial and other GM plants in any site, was purposely taken outside of a trial site, or was inadvertently dispersed outside of a trial site, GM hybrid plants could arise from the germination of seed. These plants then could spread and persist in the environment. However, it is unlikely that the stacking of the traits of the GM plants of DIRs 099, 102 and 112 (altered grain composition and abiotic stress tolerance) with those of this application (abiotic stress tolerance and micronutrient uptake) will significantly influence the invasiveness of the plants, but this is an area of uncertainty. As discussed above (scenario 2), the combination of such traits is not likely to produce a plant that is more invasive than the individual parents but it is uncertain whether the persistence of these GM plants outside of the agricultural setting may be improved. Risk scenario 5 reviews the growing of GM plants from different trials adjacent to each other, such as possibly may occur in the NGNE facilities, noting the applicant proposes using buffer zones and structuring the licence similar to other licences that have concerned the growing of different GM plants close to each other. The proposed limits and controls of the trial would minimise the possibility that seed would leave any trial site. These are discussed under risk scenario 2. All GM seed will be transported in accordance with the Regulator’s transport guidelines, which will minimise the opportunity for its dispersal. Potential harm If the vertical transfer of genes from the GM plants causes the recipient species to spread and persist in the environment to a degree greater than normally found amongst these species, they may produce one or more harms. These harms were summarised in risk scenario 2. In particular, the GM plants may act to reduce the establishment and yield of desired plants and biodiversity. As discussed in risk scenario 2, the introduced gene products of this application are unlikely to cause the GM wheat and barley lines to have a greater impact on the environment than non-GM wheat and barley, these reasons being applicable to any plants to which the genes are transferred. The weediness associated with the introduced genes of other sexually compatible GM plants growing in a NGNE facility or at the other field trial sites would be the subject of the RARMP(s) associated with their licence(s). According to the RARMPs for DIR 099, 102 and 112, there is no information to suggest that the proteins encoded by the introduced genes of those applications are likely to induce weediness in GM wheat and barley. Based upon the above discussed experience of conventional breeding (risk scenario 2), plants that are the product of hybridisation between two varieties are unlikely to have a greater impact on the environment than that of either parent (ie the stacking of genes from different GM plants will be unlikely to generate a plant more harmful than the individual GM parents).
Uncertainty Uncertainty is an intrinsic part of risk analysis6. There can be uncertainty about identifying the risk source, the causal linkage to harm, the type and degree of harm, the change of harm occurring or the level of risk. In relation to risk management, there can be uncertainty about the effectiveness, efficiency and practicality of controls. Risk analysis can be considered as part of a first tier uncertainty analysis, namely a structured, transparent process to analyse and address uncertainty when identifying, characterising and evaluating risk. However, there is always some residual uncertainty that remains. If the residual uncertainty is important and critical to decision making, then this residual uncertainty may be subjected to further analysis (=second tier uncertainty analysis), such as building ‘worst case’ scenarios, or by using meta-analysis where results from several studies are combined. There are several types of uncertainty in risk analysis (Bammer & Smithson 2008; Clark & Brinkley 2001; Hayes 2004). These include:
knowledge – data gaps, errors, small sample size, use of surrogate data variability – inherent fluctuations or differences over time, space or group, associated with diversity and heterogeneity
description – expression of ideas with symbols, language or models can be subject to vagueness, ambiguity, context dependence, indeterminacy or under-specificity perception – processing and interpreting risk is shaped by our mental processes and social/cultural circumstances, which vary between individuals and over time. For DIR 128, uncertainty is noted particularly in relation to the characterisation of:
Additional data, including information to address these uncertainties, may be required to assess possible future applications for a larger scale trial, reduced containment conditions, or the commercial release of these GM wheat or barley lines if they are selected for further development. Chapter 3, , discusses information that may be required for future releases. Risk evaluation Risk is evaluated against the objective of protecting the health and safety of people and the environment to determine the level of concern and, subsequently, the need for controls to mitigate or reduce risk. Risk evaluation may also aid consideration of whether the proposed dealings should be authorised, need further assessment, or require collection of additional information. Factors used to determine which risks need treatment may include: risk criteria level of risk uncertainty associated with risk characterisation interactions between substantive risks. Six risk scenarios were postulated whereby the proposed dealings might give rise to harm to people or the environment. The level of risk for each scenario was considered negligible in relation to both seriousness and likelihood of harm, in the context of the control measures proposed by the applicant, and considering both the short and long term. The principal reasons for these conclusions are summarised in Table 5 and include:
The Risk Analysis Framework (OGTR 2013a), which guides the risk assessment and risk management process, defines negligible risks as insubstantial with no present need to invoke actions for their mitigation. Therefore, no controls are required to treat these negligible risks. Therefore, the Regulator considers that the dealings involved in this proposed release do not pose a significant risk to either people or the environment. Risk management Background Risk management is used to protect the health and safety of people and to protect the environment by controlling or mitigating risk. The risk management plan addresses risks evaluated as requiring treatment, evaluates controls and limits proposed by the applicant, and considers general risk management measures. The risk management plan informs the Regulator’s decision-making process and is given effect through licence conditions. Under section 56 of the Act, the Regulator must not issue a licence unless satisfied that any risks posed by the dealings proposed to be authorised by the licence are able to be managed in a way that protects the health and safety of people and the environment. All licences are subject to three conditions prescribed in the Act. Section 63 of the Act requires that each licence holder inform relevant people of their obligations under the licence. The other statutory conditions allow the Regulator to maintain oversight of licensed dealings: section 64 requires the licence holder to provide access to premises to OGTR inspectors and section 65 requires the licence holder to report any information about risks or unintended effects of the dealing to the Regulator on becoming aware of them. Matters related to the ongoing suitability of the licence holder are also required to be reported to the Regulator. The licence is also subject to any conditions imposed by the Regulator. Examples of the matters to which conditions may relate are listed in section 62 of the Act. Licence conditions can be imposed to limit and control the scope of the dealings. In addition, the Regulator has extensive powers to monitor compliance with licence conditions under section 152 of the Act. Risk treatment measures for identified risks The risk assessment of risk scenarios listed in concluded that there are negligible risks to people and the environment from the proposed field trial of GM wheat and barley. These risk scenarios were considered in the context of the scale of the proposed release (Chapter 1, Section ), the proposed containment measures (Chapter 1, Section ), and the receiving environment (), and considering both the short and the long term. The Risk Analysis Framework (OGTR 2013), which guides the risk assessment and risk management process, defines negligible risks as insubstantial with no present need to invoke actions for their mitigation. Therefore, there are no licence conditions to treat these negligible risks. General risk management The limits and controls proposed in the application were important in establishing the context for the risk assessment and in reaching the conclusion that the risks posed to people and the environment are negligible. Therefore, to maintain the risk context, licence conditions have been imposed to limit the release to the proposed size, locations and duration, and to restrict the spread and persistence of the GMOs and their genetic material in the environment. The conditions are detailed in the licence and summarised in this Chapter. Licence conditions to limit and control the release Consideration of limits and controls proposed by The University of Adelaide Sections and of Chapter 1 provide details of the limits and controls proposed by The University of Adelaide in their application. These are discussed in the risk scenarios postulated for the proposed release in . Many of these proposed control measures are considered standard for GM crop trials and have been imposed by the Regulator in previous DIR licences. The appropriateness of these controls is considered further below. The duration of the field trial would be confined to six growing seasons. The trial would be limited to five sites, with a collective area of 2.5 ha per season. The small size and duration of the trial would limit the potential exposure of humans and other organisms to the GMOs (risk scenario 1). Only authorised personnel with appropriate training would be permitted to deal with the GMOs. This measure would limit the potential exposure of humans to the GMOs (risk scenario 1). The applicant proposes to monitor for the presence of rodents by placing rodent baits inside the fenced areas. Combined with the use of a monitoring zone (below), these measures should both limit exposure of rodents to the GMOs (risk scenario 1) and minimise potential dispersal of GMOs outside the trial sites by rodents (risk scenario 2). A licence condition requires that for the period while GMOs are being grown, and until a trial site has been cleaned, measures must be implemented to control rodents within a site. Birds are known to cause damage to cereal crops mostly during germination in autumn, but may feed on the crop at different times including during grain ripening (Temby & Marshall 2003). An extensive search of the literature did not identify any reports of birds other than emus transporting and dispersing wheat seed (eg through the digestive tract or taking panicles containing viable seed) or seedlings from wheat crops. The white wheat varieties have a thin seed coat (Hansen 1994) and are readily digested by birds (Yasar 2003). Therefore it is considered appropriate that no measurements are proposed to be taken to prohibit the access of birds to the trial site. However, in this respect it should be noted that both the NGNE facilities at Merredin and Katanning are covered by bird netting. Each trial site is to be surrouned by a fence. This will minimise the potential exposure of livestock and other large animals to the GMOs (risk scenario 1) and the potential dispersal of the GMOs by livestock and other large animals (risk scenario 2). The applicant proposes to surround each trial site with a 2 m buffer zone and a 10 m monitoring zone. It is a standard requirement of GM wheat and barley licences that the monitoring zone is maintained in a manner that does not attract or harbour rodents, such as keeping the area either free of vegetation or planted with vegetation mown to a height of less than 10 cm. This would serve the following purposes:
The applicant proposes that the monitoring zone would be surrounded with a 190 m isolation zone where no sexually compatible species will be grown. In addition, inspections are to be conducted for related species in the planting area, monitoring zone and isolation zone, and any found destroyed prior to flowering. The potential for pollen movement and gene flow between GM wheat and other sexually compatible species has been addressed at some length in DIR 100, DIR 102, DIR 111 and DIR 112. On the basis of the evidence detailed there, including scientific literature on gene flow, international containment measures for GM wheat trials, and the rules for producing basic and certified seed, 200 m isolation is considered adequate to minimise gene flow from the GM wheat plants to other wheat plants or other sexually related species outside the release site. Therefore the combination of a 10 m monitoring zone plus a 190 m isolation zone will mimimise gene flow to other wheat or barley crops and related species (risk scenario 4). However, at sites where there has been no cultivation or detection of wheat or barley volunteers in the isolation zone for the previous 2 years, the applicant proposes that the inspection area be reduced to 50 m. This is similar to conditions in licence DIR 102, which provide for the Regulator to give approval for the reduced inspection area, and the appropriateness of a distance of 50 m for inspection was discussed in the RARMP for DIR 102. However, the presence of related species in the isolation zone is not solely dependent on past crops or volunteers, as seed can be introduced inadvertently as contaminants in stock feed or seed for sowing. Therefore the option for a reduced inspection area is not included in the licence. The applicant proposes to plant at the same sites that DIR 102 GM wheat and barley (modified for abiotic stress tolerance) have been grown. As discussed in Chapter 2, risks associated with stacking of abiotic stress tolerance genes from DIR 128 and 102 were considered negligible. It is considered that the containment measures, in particular the monitoring requirements, would still minimise the chance of spread and persistence of any unintended stacked GMOs (risk scenarios 5 and 6). The two NGNE facilities are multi-user facilities. As there is hence the possibility that separate trials of other sexually compatible GM plants (most obviously wheat and barley) will concurrently take place in these facilities, it is important to consider the issues of vertical gene transfer and mixing of seeds between plants of different trials. The applicant mentions that DIRs 092, 093, 094, which allow the growth of plants from these three different DIRs in close proximity, requires a minimum of 4 m between plants grown under each licence (corresponding to a 2 m buffer zone for each DIR). The licence for DIR 112 specifies that other GM plants under a separate licence may be grown within the Merredin NGNE facility provided they are not grown in the Location or Buffer Zone of DIR 112, the latter being 2 m wide. A minimum distance of 4 m (which may include buffer zones) should separate the GM plants of this application and any other sexually compatible GM plants that are grown in the NGNE facilities. If any GM plants in this application are grown in one of the NGNE facilities at a time when sexually compatible GM plants authorised by another licence are concurrently being grown, seed from the GM plants of this application cannot be used in the future development of cultivars for commercial release. These measures would minimise the likelihood of mixing between seed from different trials (risk scenario 2) or vertical gene transfer (risk scenarios 5 and 6), and subsequent spread of, or exposure to, this GM material. The applicant has proposed a number of measures to minimise the persistence of any GM wheat and barley plants and seeds in the seed bank at the release site after harvest of the trial. These measures include post-harvest tillage to the depth of the original planting and irrigation to promote germination of remaining seed. After harvest, locations would be monitored at least once every 35 days for a period of 2 years and three irrigations applied. Volunteer plants that emerge would be destroyed before flowering. There is a difference in germination rates between buried grain and grain lying on the surface; grains remaining on the surface, for example following shallow tillage after harvest, can generally easily germinate and become established (Ogg & Parker 2000). Shallow tillage after harvest, combined with irrigation, will germinate much of the seed lying on the surface (Ogg & Parker 2000). However, deep cultivation in certain soil types can reduce seed viability but can also encourage prolonged dormancy in seeds as a result of a cool, moist low oxygen environment (Ogg & Parker 2000; Pickett 1989). It is therefore considered that under Australian conditions, a 2 year time period during which tillage and a number of irrigations are performed, and monitoring conducted on a regular basis with the failure to detect volunteers for a minimum of 6 months prior to the end of the time period, would effectively manage survival and persistence of viable wheat and barley seeds in the soil. It is appropriate the area receive at least 3 irrigations, at intervals of at least 28 days, with the last required irrigation occurring at a time that would promote germination of volunteers within the final volunteer-free period. A period of natural rainfall may be taken as irrigation only with the agreement of the Regulator. Evidence (such as rainfall measurements, photos etc.) that the rainfall has been sufficient to promote germination needs to be provided. Additionally, prior to the last irrigation the area must be tilled. These treatments will ensure seeds are exposed to sufficient moisture and placed at an appropriate depth for germination, as well as encouraging the microbial decomposition of any residual seed. These measures will minimise the persistence of the GMOs in the environment and are included as licence conditions. In considering potential for spread and persistence of the GMOs, it is important to consider the potential dispersal of grain during sowing and harvesting (mechanical dispersal). This is most likely to result in dispersal of grain into the area immediately around the trial. The applicant has proposed a buffer zone of 2 m around the area where the GMOs are planted, which would be subject to the same post-harvest management as the GMO planting area. The licence requires that a 2 m buffer zone and any other areas where GM material has been dispersed, including during harvest or threshing, must be monitored to manage the possibility of mechanical dispersal of seed from the trial location and its persistence after the trial. All equipment used in connection with cultivating and harvesting the GMOs are required to be cleaned on site prior to removal. The applicant has stated that any plant material taken off-site for experimental analysis will be transported according to the Regulator’s Guidelines for the transport, storage and disposal of GMOs. These are standard protocols for the handling of GMOs to minimise exposure of people and other organisms to the GMOs (risk scenario 1), dispersal into the environment and gene flow/transfer (risk scenarios 2, 3 and 4). This is included as a licence condition. The applicant does not propose using any of the plant material for human or animal consumption. FSANZ conducts mandatory premarket assessments of GM products in human foods. As the GM wheat and barley has not been assessed by FSANZ, a condition in the licence prohibits material from the trial from being used for human food or animal feed. Summary of licence conditions to be implemented to limit and control the release A number of licence conditions have been imposed to limit and control the release, based on the above considerations. These include requirements to:
Other risk management considerations All DIR licences issued by the Regulator contain a number of conditions that relate to general risk management. These include conditions relating to:
Applicant suitability In making a decision whether or not to issue a licence, the Regulator must have regard to the suitability of the applicant to hold a licence. Under section 58 of the Act, matters that the Regulator must take into account include:
On the basis of information submitted by the applicant and records held by the OGTR, the Regulator considers The University of Adelaide suitable to hold a licence. The licence includes a requirement for the licence holder to inform the Regulator of any circumstances that would affect their suitability. In addition, any applicant organisation must have access to a properly constituted Institutional Biosafety Committee and be an accredited organisation under the Act.
The University of Adelaide is required to submit a contingency plan to the Regulator before planting the GMOs. This plan would detail measures to be undertaken in the event of any unintended presence of the GM wheat outside of the permitted areas. The University of Adelaide is also required to provide a method to the Regulator for the reliable detection of the presence of the GMOs or the introduced genetic materials in a recipient organism. This instrument is required before conducting any of the licenced dealings with the GMOs.
The persons covered by the licence are the licence holder and employees, agents or contractors of the licence holder and other persons who are, or have been, engaged or otherwise authorised by the licence holder to undertake any activity in connection with the dealings authorised by the licence. Prior to growing the GMOs, The University of Adelaide is also required to provide a list of people and organisations who will be covered by the licence, or the function or position where names are not known at the time. Reporting requirements The licence obliges the licence holder to immediately report any of the following to the Regulator:
A number of written notices would also be required under the licence that would assist the Regulator in designing and implementing a monitoring program for all licensed dealings. The notices would include:
Monitoring for Compliance The Act stipulates, as a condition of every licence, that a person who is authorised by the licence to deal with a GMO, and who is required to comply with a condition of the licence, must allow inspectors and other persons authorised by the Regulator to enter premises where a dealing is being undertaken for the purpose of monitoring or auditing the dealing. Post-release monitoring continues until the Regulator is satisfied that all the GMOs resulting from the authorised dealings have been removed from the release site. If monitoring activities identify changes in the risks associated with the authorised dealings, the Regulator may also vary licence conditions, or if necessary, suspend or cancel the licence. In cases of non-compliance with licence conditions, the Regulator may instigate an investigation to determine the nature and extent of non-compliance. The Act provides for criminal sanctions of large fines and/or imprisonment for failing to abide by the legislation, conditions of the licence or directions from the Regulator, especially where significant damage to health and safety of people or the environment could result. Issues to be addressed for future releases Additional information has been identified that may be required to assess an application for a large scale or commercial release of these GM wheat or barley lines, or to justify a reduction in containment conditions. This includes:
Conclusions of the RARMP The risk assessment concludes that this proposed limited and controlled release of GM wheat and barley poses negligible risks to the health and safety of people or the environment as a result of gene technology, and that these negligible risks do not require specific risk treatment measures. However, conditions have been imposed to limit the release to the proposed size, locations and duration, and to restrict the spread and persistence of the GMOs and their genetic material in the environment, as these were important considerations in establishing the context for assessing the risks.
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