Introduction
Are you providing a submission as a representative of an organisation?
If yes, what is the name of your organisation?
The University of Western Australia
Findings - Theme 1 - Technical Issues
Findings 3 to 7:
Response
Finding 3: The University of Western Australia notes that that the definitions in the Gene Technology Act 2000 and Regulations 2001 are difficult to maintain and regulate in a rapidly changing environment. Furthermore, the social and ethical issues surrounding these definitions create a challenging environment. We would like to voice our support for the changing of the definitions, while noting that our response to the option paper called for a balanced approach to be taken. Specifically, that the regulations should be based upon a logical and risk based analysis of the outcomes that are produced, rather than a regulation based on process. In addition, as noted by us, the main advantage of this option is that it will result in the GMO-classification and regulation of SDN-3, ie the insertion of long stretches of foreign DNA into the genome. At the same time, this option rules out short oligo-directed repair (SDN-2), as well as non-homologous end joining (SDN-1) from GMO classification and regulation.
From a scientific perspective, it is possible for any of the SDN approaches to significantly alter the phenotype of the organism; with potentially harmful effects should the organism be released. However, from a practical perspective SDN-1 and SDN-2 will induce changes that could occur naturally and will in each case produce very small-scale localised mutations. Although mutagenesis by random transposition does create GMOs, mutagenesis by chemical mutagens are not classified as GMOs even though this has the same outcome as SDN-1 and SDN-2 (ie random point mutations and small indels). Therefore it would be illogical to exempt mutageneses by chemical mutagens from the GMO definition, yet include SDN-1 and SDN-2 approaches. If, at a future date, ‘mutagenesis’ was to be re-classified as creating a GMO, then SDN-1 and SDN-2 could also be included in the mutagenesis category. This needs further clarification as mutagenesis by transposition does create GMO mutants, while EMS mutagenesis does not.
At present, the regulatory burden for standard GMO experiments is not onerous. Thus, adding SDN technology to the existing framework should not be problematic. This committee would caution against future new regulatory burdens, for example the requirement of whole genome sequencing for every GMO organism created in a laboratory setting (eg. Mammalian Cell lines, plants, mice). There should be a progression of regulation as an organism moves closer to potential application or use as a product. Once a milestone is passed along this pipeline, then perhaps at that point a full genome sequence for the organism could be performed as a form of due diligence before progressing to the next stage of regulation.
Finding 4: The University of Western Australia agrees that synthetic biology is and should remain within the scope of the scheme, and supports the ACOLA review of the regulation.
Finding 5: While UWA supports removing any reference to human beings being within the scope of the scheme, we ask that caution be exercised. This should be independent of human cell lines, and independent of research on human embryos, and should only be referring to entire human beings as per the Research Involving Human Embryos Act 2002. Further, the University asks that the question of who shall be responsible for the regulation of this research should be looked at carefully. We suggest that the NHMRC has the ethical capacity to examine this most effectively, but that technical skill should also be sought, perhaps from the OGTR.
Findings 6 and 7: UWA again would suggest that a risk based approach would be most logical in this instance. The purpose of the GM production should not influence the category or the regulatory controls. All regulations should be based upon a logical and risk based analysis of the outcomes that are produced, rather than a regulation based on process or intention of the research.
From a scientific perspective, it is possible for any of the SDN approaches to significantly alter the phenotype of the organism; with potentially harmful effects should the organism be released. However, from a practical perspective SDN-1 and SDN-2 will induce changes that could occur naturally and will in each case produce very small-scale localised mutations. Although mutagenesis by random transposition does create GMOs, mutagenesis by chemical mutagens are not classified as GMOs even though this has the same outcome as SDN-1 and SDN-2 (ie random point mutations and small indels). Therefore it would be illogical to exempt mutageneses by chemical mutagens from the GMO definition, yet include SDN-1 and SDN-2 approaches. If, at a future date, ‘mutagenesis’ was to be re-classified as creating a GMO, then SDN-1 and SDN-2 could also be included in the mutagenesis category. This needs further clarification as mutagenesis by transposition does create GMO mutants, while EMS mutagenesis does not.
At present, the regulatory burden for standard GMO experiments is not onerous. Thus, adding SDN technology to the existing framework should not be problematic. This committee would caution against future new regulatory burdens, for example the requirement of whole genome sequencing for every GMO organism created in a laboratory setting (eg. Mammalian Cell lines, plants, mice). There should be a progression of regulation as an organism moves closer to potential application or use as a product. Once a milestone is passed along this pipeline, then perhaps at that point a full genome sequence for the organism could be performed as a form of due diligence before progressing to the next stage of regulation.
Finding 4: The University of Western Australia agrees that synthetic biology is and should remain within the scope of the scheme, and supports the ACOLA review of the regulation.
Finding 5: While UWA supports removing any reference to human beings being within the scope of the scheme, we ask that caution be exercised. This should be independent of human cell lines, and independent of research on human embryos, and should only be referring to entire human beings as per the Research Involving Human Embryos Act 2002. Further, the University asks that the question of who shall be responsible for the regulation of this research should be looked at carefully. We suggest that the NHMRC has the ethical capacity to examine this most effectively, but that technical skill should also be sought, perhaps from the OGTR.
Findings 6 and 7: UWA again would suggest that a risk based approach would be most logical in this instance. The purpose of the GM production should not influence the category or the regulatory controls. All regulations should be based upon a logical and risk based analysis of the outcomes that are produced, rather than a regulation based on process or intention of the research.
Findings - Theme 2 - Regulatory Issues
Findings 8 - 15:
Response
Finding 8: The Regulatory Trigger
The University of Western Australia acknowledges that changing the scheme to a product trigger rather than the current process trigger would create considerable complexity within the regulatory system. However, we agree with the stakeholders that have asserted that “A product may be considered novel and thus captured by the regulatory scheme if it has one or more new or changed traits, or a new use, regardless of whether it has been developed through the application of gene technology or another process.” The regulatory trigger should be the actual effect of the product, not the process used to achieve it. In addition, the regulations should reflect a logical risk based approach, so that the end result is considered carefully in terms of its social, ethical, environmental, and scientific effects. We believe that the evolution of GM technology is such that a process trigger is nearly impossible to legislate, and that the modification of the scheme to a product trigger is inevitable. The delaying of this modification will cause unnecessary confusion and the possibility of reduced regulatory oversight in a rapidly changing environment.
Finding 9: Tiered Risk
The University of Western Australia wholly agrees with the concept of a tiered risk system, with exit points and the ability to move organisms between categories based on new data. We would specifically like to ask the Regulator to re-examine the classification of long term low risk GM animals used as a vehicle for research (such as mice).
Finding 10: Streamlining
The University of Western Australia agrees in principle with the concept of streamlining the administration. In particular, we enthusiastically agree with harmonisation efforts and with simplifying NLRD requirements. However, the following proposals for streamlining have raised concerns:
• Facility certifications can be pre-approved by IBCs prior to formal approval by the OGTR, but certifications should not be completely devolved to the IBCs.
• DNIR licenses should remain with the OGTR and should NOT be devolved to the IBCs
• DIR licenses likewise should NOT be devolved to the IBCs
Finding 11: the Register
The University of Western Australia supports the finding that consideration be given to removing the requirement for the Regulator to make a legislative instrument to add a GMO to the Register. This requirement is not only legislatively cumbersome, but it adds additional risk in the process of tabling the instrument in Parliament and having it debated by non-scientists. Requiring the Regulator to consult with states and territories and the public when proposing to include a new GMO on the Register is an acceptable form of check and balance on the power.
Finding 12: DIY Biology
The University of Western Australia agrees that it would be beneficial for the Regulator to ensure that gene technology regulatory requirements are widely known, ensure good risk management practices are followed, and to provide guidance to the DIY biology community on responsible research. In addition, we believe that there may be scope within the academic community to aid with this type of public outreach.
Finding 13 and 14: Flexibility and agility of the scheme
The University of Western Australia fully agrees that it is imperative that the Scheme be empowered to be more flexible and agile, to respond to a rapidly changing environment. The current Act and regulatory arrangements do not provide enough agility or flexibility to respond quickly to new technology. We agree with the proposed options for increasing this flexibility.
Finding 15: Market access and trade
The University of Western Australia supports this finding, and further agrees that small-scale, niche researchers or Australian owned plant breeding companies are disadvantaged by the regulatory approval process as it currently stands. Researchers of this scale have been placed in the position of having to sell or licence their intellectual property to an entity with the financial capacity to commercialise the GMO. This has the effect of stifling research and will have the effect of minimizing Australia’s contribution to this valuable industry.
The University of Western Australia acknowledges that changing the scheme to a product trigger rather than the current process trigger would create considerable complexity within the regulatory system. However, we agree with the stakeholders that have asserted that “A product may be considered novel and thus captured by the regulatory scheme if it has one or more new or changed traits, or a new use, regardless of whether it has been developed through the application of gene technology or another process.” The regulatory trigger should be the actual effect of the product, not the process used to achieve it. In addition, the regulations should reflect a logical risk based approach, so that the end result is considered carefully in terms of its social, ethical, environmental, and scientific effects. We believe that the evolution of GM technology is such that a process trigger is nearly impossible to legislate, and that the modification of the scheme to a product trigger is inevitable. The delaying of this modification will cause unnecessary confusion and the possibility of reduced regulatory oversight in a rapidly changing environment.
Finding 9: Tiered Risk
The University of Western Australia wholly agrees with the concept of a tiered risk system, with exit points and the ability to move organisms between categories based on new data. We would specifically like to ask the Regulator to re-examine the classification of long term low risk GM animals used as a vehicle for research (such as mice).
Finding 10: Streamlining
The University of Western Australia agrees in principle with the concept of streamlining the administration. In particular, we enthusiastically agree with harmonisation efforts and with simplifying NLRD requirements. However, the following proposals for streamlining have raised concerns:
• Facility certifications can be pre-approved by IBCs prior to formal approval by the OGTR, but certifications should not be completely devolved to the IBCs.
• DNIR licenses should remain with the OGTR and should NOT be devolved to the IBCs
• DIR licenses likewise should NOT be devolved to the IBCs
Finding 11: the Register
The University of Western Australia supports the finding that consideration be given to removing the requirement for the Regulator to make a legislative instrument to add a GMO to the Register. This requirement is not only legislatively cumbersome, but it adds additional risk in the process of tabling the instrument in Parliament and having it debated by non-scientists. Requiring the Regulator to consult with states and territories and the public when proposing to include a new GMO on the Register is an acceptable form of check and balance on the power.
Finding 12: DIY Biology
The University of Western Australia agrees that it would be beneficial for the Regulator to ensure that gene technology regulatory requirements are widely known, ensure good risk management practices are followed, and to provide guidance to the DIY biology community on responsible research. In addition, we believe that there may be scope within the academic community to aid with this type of public outreach.
Finding 13 and 14: Flexibility and agility of the scheme
The University of Western Australia fully agrees that it is imperative that the Scheme be empowered to be more flexible and agile, to respond to a rapidly changing environment. The current Act and regulatory arrangements do not provide enough agility or flexibility to respond quickly to new technology. We agree with the proposed options for increasing this flexibility.
Finding 15: Market access and trade
The University of Western Australia supports this finding, and further agrees that small-scale, niche researchers or Australian owned plant breeding companies are disadvantaged by the regulatory approval process as it currently stands. Researchers of this scale have been placed in the position of having to sell or licence their intellectual property to an entity with the financial capacity to commercialise the GMO. This has the effect of stifling research and will have the effect of minimizing Australia’s contribution to this valuable industry.
Findings - Theme 3 - Governance Issues
Findings 16 - 28:
Response
Finding 27-28: The University of Western Australia shares the concerns of stakeholders who stated that a cost recovery model has the potential to:
• Stifle innovation (discouraging research and investment in Australia and inhibiting the commercialisation of GM products);
• erode the community’s trust in the independence of the Regulator;
• erode regulated stakeholders’ trust in the OGTR if there is a perception (or reality) of over-servicing users who are charged per site/facility inspection;
• and impose unreasonable financial burden on research organisations that may not be sustainable in the medium to long term, noting the financial commitments that organisations already incur by funding Institutional Biosafety Committees (IBCs) and ensuring other regulatory obligations are met.
We do not believe that the under-resourcing of the OGTR should be solved in a cost-recovery model that will create a conflict of interest and will impose such an unfair burden on an already administratively overburdened University sector. In addition, other proposals within this document are asking the University IBCs to do more of the work for the OGTR. It would be vastly discriminatory and unfair to ask the academics and Universities to both do additional work and to pay the OGTR in a cost recovery model. Such a scheme will not have the regulatory and compliance effect that is desired.
• Stifle innovation (discouraging research and investment in Australia and inhibiting the commercialisation of GM products);
• erode the community’s trust in the independence of the Regulator;
• erode regulated stakeholders’ trust in the OGTR if there is a perception (or reality) of over-servicing users who are charged per site/facility inspection;
• and impose unreasonable financial burden on research organisations that may not be sustainable in the medium to long term, noting the financial commitments that organisations already incur by funding Institutional Biosafety Committees (IBCs) and ensuring other regulatory obligations are met.
We do not believe that the under-resourcing of the OGTR should be solved in a cost-recovery model that will create a conflict of interest and will impose such an unfair burden on an already administratively overburdened University sector. In addition, other proposals within this document are asking the University IBCs to do more of the work for the OGTR. It would be vastly discriminatory and unfair to ask the academics and Universities to both do additional work and to pay the OGTR in a cost recovery model. Such a scheme will not have the regulatory and compliance effect that is desired.
Findings - Theme 4 - Social and Ethical Issues
Findings 29 to 33:
Response
Findings 29 to 33: The University of Western Australia agrees with the social and ethical findings, and would suggest that the university system could also play a role in public education and communication.