Summary of issues raised in submissions received from the public on the consultation RARMP for DIR 095

The Regulator received two submissions from the public on the consultation RARMP. These submissions, summarised in the table below, raised issues relating to human health and safety and the environment. These were considered in the context of currently available scientific evidence in finalising the RARMP that formed the basis of the Regulator’s decision to issue the licence.

Position (general tone): n = neutral; x = do not support; y = support

Issues raised: DR: data requirements; EN: environmental issues; H: human health; HGT: horizontal gene transfer; OSA: outside scope of assessment; R: regulatory process; UE: unintended effects.

Other abbreviations: GE: genetically engineered; GM: Genetically Modified; GTR: the Gene Technology Regulator; RARMP: Risk Assessment and Risk Management Plan.

Type: I: individual

Sub. No:TypePositionIssueSummary of issues raisedComment
1IxUEObjects to the release on the grounds of genetic instability.Although the stability of the GM sugarcane lines for release has not been assessed, GM traits in sugarcane have been shown to be stably inherited, as is discussed in the RARMP. The spread and persistence of the GM sugarcane would be restricted by the limits and controls imposed upon this release.
UE, ENObjects to the release on the grounds of the unforseen ecological consequences of growing GE life forms in environments with which they are not harmonised.DIR 095 is a limited and controlled release for the purpose of conducting experiments, including field characterisation of the GM sugarcane lines. The RARMP concluded that there were no identified risks to the environment from the GM sugarcane, and measures have been imposed to restrict their dissemination and persistence.

The RARMP identifies information which may be required to assess future applications, such as phenotypic characterisation of the GM lines, including traits indicative of weediness. This information would be important in assessing the potential ecological consequences of larger scale or commercial releases of the GM sugarcane.

HObjects to the release on the grounds of the lack of social acceptance of GE foods, and unavoidability of consuming them once they are released. States that the threat of loss of natural sustenance is a considerable strain on human health and sense of well-being.Material from the field trial is not allowed to be consumed by humans or animals.

Social acceptance of GM food is outside the scope of the assessment conducted under the Gene Technology Act.

OSAObjects to the release on the grounds that climate change and the prospect of famine and disease have been caused by the impact of technology on the natural world, and by humans seeking to control nature.Noted. The appropriateness of using gene technology is outside the scope of issues which the GTR must have regard to when deciding whether or not to issue a licence.
2IxHGT, ENRequests that DIR 095 exclude drought tolerance transgenic plants for reasons provided in relation to previous releases.Please refer to comments addressing these submissions in the RARMPs for previous releases (DIRs 077/2007, 080/2007, 081/2007, 083/2007).
HGTConsiders that evidence of problematic horizontal gene transfer continues to accumulate to the point that it would be negligent for the GTR to continue to claim that it provides no identifiable risk.
Considers that the GTR must act to restrict release into the environment of genetically modified plants where transformation was achieved using Agrobacterium because of the increasingly realised and accepted higher risk of HGT. Given present knowledge it is unacceptable to allow release of GM plants produced by Agrobacterium-mediated transformation.
Potential risks to human health and safety and environment arising as a result of HGT were assessed in the RARMP. Important considerations were that:
  • the sequences are already widely present in the environment, and so are naturally available for HGT
  • assessment of the potential toxicity or allergenicity of the expressed proteins found no evidence that they posed a risk to human health and safety and the environment. Given the rarity of HGT occurring and that adverse consequence were found to be unlikely, it was concluded that the potential for an adverse outcome was not an identified risk.
Agrobacterium-mediated transformation has been used over a considerable period of time, and adverse effects have not been detected.
HGTStates that Ulker et al. (2008) confirm that use of the Agrobacterium transformation vector frequently (1:250) results in transfer and subsequent insertion into the host genome, of significant stretches (possibly 18 kb) of bacterial DNA (not necessarily from the Ti plasmid) linked to the transgene.
Considers that the large Agrobacterium sequence linked to the T-DNA and incorporated into the host genome represents an homologous anchor for HGT from the plant to pathogenic Agrobacterium spp., related bacteria or as yet uncharacterised pathogenic bacteria, fungi, yeast and viruses. Considers that the 18 kb size of the anchor offers significant potential for a wide range of homologies, and it is obvious that a fragment of 18 kb will have some homology to DNA in many species of micro-organisms.
States that it is argued that HGT occurs at low frequency and so is not an identified risk, however considers that this is not true when homology is considered. Argues that HGT is well documented to occur at worrying frequencies (naturally and experimentally) and asks why these transformants have not been excluded from the licence?
Ulker et al. (2008) found that 0.4% of Arabidopsis transformed by Agrobacterium-mediated transformation contained Agrobacterium chromosomal sequences, with sequences of over 18 kb being detected in linkage with T-DNAs. As the same mechanism of Agrobacterium-mediated gene transfer operates in sugarcane as in Arabidopsis these results are relevant to sugarcane, however the frequency of transfer of Agrobacterium chromosomal sequence in sugarcane is unknown.
HGT to microorganisms is much more likely to occur from bacteria (such as Agrobacterium) than from plants (such as sugarcane). Plant genomes have been shown to contain sequences of bacterial origin, however these sequences have not given rise to HGT of plant genes to microorganisms. While presence of Agrobacterium sequences in GM plants could increase the frequency of HGT to species with homologous sequences, the most frequent outcome of this would be presence of Agrobacterium sequences in the HGT recipient organism. This outcome is already possible due to widespread presence of Agrobacterium in the environment.
The basis for the assessment carried out in the RARMP is to consider hazards arising as a result of release of the GM plants compared to what might naturally occur. For the current release the source organisms for the GM traits are generally widely persistent in the environment and so these sequences are already available for transfer.
Agrobacterium-mediated transformation has been used over a considerable period of time, and adverse effects have not been detected.
CWhy does the RARMP simply accept the applicant’s claim that they will test for Agrobacterium with PCR?
Considers that the applicant should identify the sequences they will test for, and what DNA will be tested.
States that tests should be conducted to detect Agrobacterium DNA in the plant genome.
The RARMP assessed the dealings which BSES applied to conduct, which included PCR testing for the presence of Agrobacterium, and the licence conditions include PCR testing as a requirement.

BSES provided the sequence of the PCR primers they plan to use to detect Agrobacterium in their application.

Given that the presence of Agrobacterium DNA in the plant genome is not considered to give rise to an identified risk in relation to the potential for HGT, measures requiring it be tested for were not imposed.

HGTConsiders that pathogenic Agrobacterium could transfer the traits acquired by HGT to other species which Agrobacterium can transform, which include plants, fungi, yeast and animal cells. States that the potential for this depends on where the traits insert in the bacterial genome, but it is likely that 1:250 such Agrobacterium would be capable of transforming plants with the cloned gene.The chain of events necessary for the traits in the GM sugarcane to be transferred to Agrobacterium and then to other organisms includes:
  • generation of GM sugarcane plants in which the left and right border sequences of the T-DNA, which are not transferred intact during plant transformation, are reconstituted by chance events.
  • HGT of the entire gene and flanking border sequences from GM sugarcane to a strain of Agrobacterium capable of transforming plants, fungi and other species. Tumour-inducing plasmids carrying the genes necessary for T-DNA transfer occur only in a small percentage of natural A. tumefaciens populations in soil.
  • Contact between the recipient A. tumefaciens and other organisms in appropriate environmental conditions for transformation to occur.
  • For plants and animals, transformation of germ-line cells such that the received trait can be passed to offspring.
While a chain of events giving rise to this outcome is plausible, there is a very small probability of each of these steps occurring, and so it is extremely unlikely for this entire chain of events to happen. Further, should all of these events occur, they would not necessarily result in harm.
HGT, DRConsiders that the known potential Agrobacterium flanking sequences must be compared to other pathogens likely to be present in the soil at the release sites, which could readily be done as a database search. Argues that without this analysis, the potential for increased virulence of such pathogens due to transfer of stress tolerance genes cannot be ignored and the GTR is not in a position to claim no identified risk.Risks to the health and safety of people or the environment that might arise as a result of HGT from the GM sugarcane to bacteria or fungi have been considered in the context of this limited and controlled release. The suggested analysis was not required in this assessment because consideration of the potential consequences concluded that it was unlikely that HGT would give rise to adverse consequences (see below). In addition, it is considered unlikely that HGT of the introduced genes from the GM sugarcane to microorganisms would occur.

It is considered unlikely that HGT of the introduced genes from the GM sugarcane to microorganisms would occur and unlikely that such HGT would give rise to adverse consequences (see below).

Agrobacterium occurs widely in the environment and so sequences from Agrobacterium are already available for horizontal gene transfer to other soil microorganisms.

HGT, DRStates that the extent of expression of the cloned inserts (given their overexpression promoters and regulatory sequences) in bacteria, yeast and fungi needs to be examined or determined. Considers that the extent to which this would produce more virulent micro-organisms requires further speculation, and this possibility is high for stress tolerance transcription regulators (eg regulating osmosis or salt exclusion).Risks to the health and safety of people or the environment that might arise as a result of HGT from the GM sugarcane to bacteria or fungi have been considered in the context of this limited and controlled release. The suggested analysis was not required in this assessment because consideration of the potential consequences concluded that it was unlikely that HGT would give rise to adverse consequences.

It is considered highly unlikely that HGT of the introduced genes could produce drought tolerant bacteria or fungi. Given the vast differences in gene regulation between plants and bacteria or fungi, it is highly unlikely that genes conferring drought tolerance on plants would give rise to the same trait in bacteria or fungi. The eukaryotic promoters (which are not restricted to constitutive expression promoters) used in DIR 095 are unlikely to function similarly if transferred to bacteria or fungi. The encoded proteins and their products interact with a wide range of plant proteins which are not known to be present in bacteria or fungi.

RConsiders genetic regulation is a joke and the GTR is redundant when releases of GM plants produced by Agrobacterium transformation is allowed, particularly when they have not been characterised properly or at all, and where the reason given for this is that PC2 facilities are not available.The current assessment made use of published knowledge of effects of the genes of interest in other GM plants, published knowledge of the effects of GM plants conferred with similar traits, and data provided by the applicant relating to some of the genes of interest.

The RARMP for this limited and controlled release concludes that risks to human health and the environment are negligible. The RARMP also identifies information which may be required to assess a larger-scale or commercial release, including phenotypic and molecular characterisation of the GM sugarcane lines.