Introduction
Are you providing a submission as a representative of an organisation?
If yes, what is the name of your organisation?
Association of Biosafety Australia and New Zealand (ABSANZ)
Findings - Theme 1 - Technical Issues
Findings 3 to 7:
Response
Finding 3:
ABSANZ supports the adoption of consistent definitions and notes that that any change in the definitions should not include any humans as GMOs. In addition, where an organism has been modified in a way that is indistinguishable from that found in nature, i.e. where any mutation would be less than that arrived at by traditional breeding techniques, there should be no inclusion under the Act. Thus, regulation should be about outcomes (‘outcome focused’ not processes. It is not intuitive, nor appropriate to exempt ‘mutagenesis’ by chemical mutagens from the GMO definition, yet include SDN-1 and SDN-2 approaches. However, 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. Another complication would be that monitoring and enforcement of such mutagenesis practices under the legislation would occupy significant resources, and as such may not be achieved and may detract from the credibility of the legislative process.
ABSANZ does not support any approach that requires whole genome sequencing for every GMO organism created in a laboratory setting (e.g. Mammalian Cell lines, plants, mice). This approach may eventually be used before the release of some organisms, as a form of due diligence, but to impose on all GMOs might be considered unnecessarily onerous and resource intensive.
Finding 4:
ABSANZ agrees that synthetic biology is, and should remain within the scope of the scheme, and supports the ACOLA review of the regulation.
Finding 5:
ABSANZ agrees that the scheme should not regulate human gene therapies. However, where other regulatory oversight may be required, and which requires both ethical and other regulatory oversight (e.g. TGA), ABSANZ supports a joint approach to finalise decisions on this process. Trials should be considered on a case-by-case basis rather than set rules as the science is changing rapidly.
To maximise benefits to health and to obtain results within grant time frames, a short-coordinated approval process which involves relevant regulatory agencies is required. A lack of parallel approval led, in one instance which involved administration of T cells incorporating an inducible suicide gene into humans, to extended delays. Where possible, a coordinated approval process could be trialed.
Finding 6 & 7:
Australia does not have good track record for release of biological control agents. There is a lack of knowledge in areas of interdependency of organisms within habitats. For example, while humans may wish to remove mosquitoes from an environment it may not be to the benefit of other organisms that might depend on eating their larvae.
Therefore, any agency authorised to manage such releases must have a broad knowledge base. Any committee should necessarily involve ecologists in addition to OGTR staff. In addition, any regulation 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.
ABSANZ supports the adoption of consistent definitions and notes that that any change in the definitions should not include any humans as GMOs. In addition, where an organism has been modified in a way that is indistinguishable from that found in nature, i.e. where any mutation would be less than that arrived at by traditional breeding techniques, there should be no inclusion under the Act. Thus, regulation should be about outcomes (‘outcome focused’ not processes. It is not intuitive, nor appropriate to exempt ‘mutagenesis’ by chemical mutagens from the GMO definition, yet include SDN-1 and SDN-2 approaches. However, 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. Another complication would be that monitoring and enforcement of such mutagenesis practices under the legislation would occupy significant resources, and as such may not be achieved and may detract from the credibility of the legislative process.
ABSANZ does not support any approach that requires whole genome sequencing for every GMO organism created in a laboratory setting (e.g. Mammalian Cell lines, plants, mice). This approach may eventually be used before the release of some organisms, as a form of due diligence, but to impose on all GMOs might be considered unnecessarily onerous and resource intensive.
Finding 4:
ABSANZ agrees that synthetic biology is, and should remain within the scope of the scheme, and supports the ACOLA review of the regulation.
Finding 5:
ABSANZ agrees that the scheme should not regulate human gene therapies. However, where other regulatory oversight may be required, and which requires both ethical and other regulatory oversight (e.g. TGA), ABSANZ supports a joint approach to finalise decisions on this process. Trials should be considered on a case-by-case basis rather than set rules as the science is changing rapidly.
To maximise benefits to health and to obtain results within grant time frames, a short-coordinated approval process which involves relevant regulatory agencies is required. A lack of parallel approval led, in one instance which involved administration of T cells incorporating an inducible suicide gene into humans, to extended delays. Where possible, a coordinated approval process could be trialed.
Finding 6 & 7:
Australia does not have good track record for release of biological control agents. There is a lack of knowledge in areas of interdependency of organisms within habitats. For example, while humans may wish to remove mosquitoes from an environment it may not be to the benefit of other organisms that might depend on eating their larvae.
Therefore, any agency authorised to manage such releases must have a broad knowledge base. Any committee should necessarily involve ecologists in addition to OGTR staff. In addition, any regulation 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
As stated earlier, ABSANZ supports an outcome-based product approach as opposed to a process approach. That would also allow a better characterization of risk to human health and safety etc. as opposed to basing it on the native organism.
Finding 9:
ABSANZ supports the consideration of risk by a broader panel of experts that includes microbiologists and hospital infectious disease physicians as well as OGTR staff.
Where possible, a mechanism to amend risk associated with organisms, and therefore their classification should be used to facilitate consideration outside a Parliamentary process.
Finding 10:
ABSANZ strenuously supports streamlining and would be happy to be involved through its activities in relation to Australian Standards etc.
Finding 11:
ABSANZ 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 and supports efforts to improve the use of the Register, as it does not appear to be working as intended when the Act was established. Removal of the requirement for the dealing to require license authorisation seems an appropriate starting point.
Finding 12:
ABSANZ supports an approach to raise awareness about gene technology and notes that there may be a need to reach out to suppliers of materials and equipment used to conduct gene technology experiments and consider the possibility of end user statements that include IBC approval for work to be conducted. This may help to improve awareness and reduce the need for monitoring and enforcement activities.
Finding 13:
ABSANZ supports a system of principles-based regulation especially where it may apply to lower risk (exempt/ PC1) dealings, to improve flexibility and the ability to respond rapidly to a changing technological environment. The current Act and regulatory arrangements do not provide enough agility or flexibility to respond quickly to modern technology. We agree with the proposed options for increasing this flexibility.
Finding 15:
ABSANZ 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 license 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.
ABSANZ supports a consistency of GMO definitions that is contemporary and world’s best practice. In addition, it is essential that OGTR considers international obligations in relation to relevant dealings. However, as some requirements are contextual, it is essential that unnecessary international requirements not be imposed without due consideration.
As stated earlier, ABSANZ supports an outcome-based product approach as opposed to a process approach. That would also allow a better characterization of risk to human health and safety etc. as opposed to basing it on the native organism.
Finding 9:
ABSANZ supports the consideration of risk by a broader panel of experts that includes microbiologists and hospital infectious disease physicians as well as OGTR staff.
Where possible, a mechanism to amend risk associated with organisms, and therefore their classification should be used to facilitate consideration outside a Parliamentary process.
Finding 10:
ABSANZ strenuously supports streamlining and would be happy to be involved through its activities in relation to Australian Standards etc.
Finding 11:
ABSANZ 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 and supports efforts to improve the use of the Register, as it does not appear to be working as intended when the Act was established. Removal of the requirement for the dealing to require license authorisation seems an appropriate starting point.
Finding 12:
ABSANZ supports an approach to raise awareness about gene technology and notes that there may be a need to reach out to suppliers of materials and equipment used to conduct gene technology experiments and consider the possibility of end user statements that include IBC approval for work to be conducted. This may help to improve awareness and reduce the need for monitoring and enforcement activities.
Finding 13:
ABSANZ supports a system of principles-based regulation especially where it may apply to lower risk (exempt/ PC1) dealings, to improve flexibility and the ability to respond rapidly to a changing technological environment. The current Act and regulatory arrangements do not provide enough agility or flexibility to respond quickly to modern technology. We agree with the proposed options for increasing this flexibility.
Finding 15:
ABSANZ 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 license 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.
ABSANZ supports a consistency of GMO definitions that is contemporary and world’s best practice. In addition, it is essential that OGTR considers international obligations in relation to relevant dealings. However, as some requirements are contextual, it is essential that unnecessary international requirements not be imposed without due consideration.
Findings - Theme 3 - Governance Issues
Findings 16 - 28:
Response
Finding 16:
ABSANZ endorses the credibility of the regulatory framework and the independence of the Regulator and notes that under the leadership of various Regulators and advisory groups, there have not been any significant releases from containment. That said, there should always be appropriate consideration of affiliations of advisory committees to minimise any perceptions of conflict of interest.
Finding 17:
ABSANZ supports a nationally consistent regulatory framework but notes the interdependency of State legislation and Commonwealth legislation and that the latter is not always amended as expediently as would be expected. However, to the extent that there are inconsistencies, and in accordance with s109 of the Constitution, Commonwealth legislation prevails. As such, this should not prove too much of an obstacle for stakeholders.
Finding 21:
ABSANZ believes that potential economic and health benefits could also be achieved more expediently by approval processes that make more efficient use of the information provided by IBCs in the approval process. This is particularly relevant for dealings considered to be of a lower risk and for which oversight could be provided at an institutional level
Finding 24-26:
ABSANZ believes that there is the possibility for duplication but that this can be ameliorated by clearly delineating responsibilities and by having a single application process. For example, with respect to clinical trials of genetically modified immune cells, there is a need for the TGA to be involved as the cells may be biologicals. OGTR also has a role to consider any potential release from containment. Finally, an institution and a human research ethics committee have responsibilities. In this case, the TGA has primacy given its regulatory role and as such should be perhaps coordinated through TGA. In any respect, having a single application process for the above example would be highly beneficial.
Finding 27:
ABSANZ agrees that imposition of cost recovery would have detrimental effects on the sector and would change the interactions between stakeholders and OGTR. This has already been observed in relation to compliance with other legislation and should be avoided at all costs. For example, full cost recovery is already an issue for the Biosecurity Act compliance, with many stakeholders believing that the cost of regulation is not commensurate with the risks associated with activities. In this regard, it is a necessary step to devolve more responsibility to institutions in relation to lower risk dealings.
Finding 28:
ABSANZ believes that the level of future regulatory activities, whilst they may increase, could be offset by consideration of devolving more responsibility for lower containment level research to institutions. This approach, which would be risk based, would be in keeping with other efforts to reduce the effect of burgeoning regulation.
ABSANZ endorses the credibility of the regulatory framework and the independence of the Regulator and notes that under the leadership of various Regulators and advisory groups, there have not been any significant releases from containment. That said, there should always be appropriate consideration of affiliations of advisory committees to minimise any perceptions of conflict of interest.
Finding 17:
ABSANZ supports a nationally consistent regulatory framework but notes the interdependency of State legislation and Commonwealth legislation and that the latter is not always amended as expediently as would be expected. However, to the extent that there are inconsistencies, and in accordance with s109 of the Constitution, Commonwealth legislation prevails. As such, this should not prove too much of an obstacle for stakeholders.
Finding 21:
ABSANZ believes that potential economic and health benefits could also be achieved more expediently by approval processes that make more efficient use of the information provided by IBCs in the approval process. This is particularly relevant for dealings considered to be of a lower risk and for which oversight could be provided at an institutional level
Finding 24-26:
ABSANZ believes that there is the possibility for duplication but that this can be ameliorated by clearly delineating responsibilities and by having a single application process. For example, with respect to clinical trials of genetically modified immune cells, there is a need for the TGA to be involved as the cells may be biologicals. OGTR also has a role to consider any potential release from containment. Finally, an institution and a human research ethics committee have responsibilities. In this case, the TGA has primacy given its regulatory role and as such should be perhaps coordinated through TGA. In any respect, having a single application process for the above example would be highly beneficial.
Finding 27:
ABSANZ agrees that imposition of cost recovery would have detrimental effects on the sector and would change the interactions between stakeholders and OGTR. This has already been observed in relation to compliance with other legislation and should be avoided at all costs. For example, full cost recovery is already an issue for the Biosecurity Act compliance, with many stakeholders believing that the cost of regulation is not commensurate with the risks associated with activities. In this regard, it is a necessary step to devolve more responsibility to institutions in relation to lower risk dealings.
Finding 28:
ABSANZ believes that the level of future regulatory activities, whilst they may increase, could be offset by consideration of devolving more responsibility for lower containment level research to institutions. This approach, which would be risk based, would be in keeping with other efforts to reduce the effect of burgeoning regulation.
Findings - Theme 4 - Social and Ethical Issues
Findings 29 to 33:
Response
Finding 29:
ABSANZ supports efforts to improve communication around the regulatory scheme and importantly in the areas of ethics and integrity. This would be best achieved by an entity outside OGTR or at least seen as independent. However, public rebuttal of "nonsense claims "relating” to GMOs should be made where possible by the Regulator.
ABSANZ supports efforts to improve communication around the regulatory scheme and importantly in the areas of ethics and integrity. This would be best achieved by an entity outside OGTR or at least seen as independent. However, public rebuttal of "nonsense claims "relating” to GMOs should be made where possible by the Regulator.