Introduction
Are you providing a submission as a representative of an organisation?
If yes, what is the name of your organisation?
AusBiotech
Findings - Theme 1 - Technical Issues
Findings 3 to 7:
Response
Finding 3 – The Review found that there are existing definitions in the Gene Technology Act 2000 and Gene Technology Regulations 2001 that may not appropriately classify a range of advances in technology (for example, the definitions of ‘gene technology’ and ‘genetically modified organism’, including use of the terms ‘other genetic material’ and ‘foreign’).
In both the Australian and international context, the value of having consistent definitions is well understood, as is recognition that definitions have a primary role in the classification of technologies and subsequent regulatory requirements. Any examination of definitions should therefore take into account concurrent work, including the current Technical Review of the Gene Technology Regulations 2001, as well as ongoing work internationally.
AusBiotech supports this finding and would recommend that any proposed changes to definitions consider both regulatory and trade implications as to their use.
Finding 4 – The Review found that synthetic biology is currently within the scope of the Scheme, and there is a high degree of support for this to continue. Work is currently being undertaken by the Australian Council of Learned Academies (ACOLA) which may further inform this issue going forward, including determining the most appropriate mechanism(s) to ensure the appropriate level of regulation of synthetic biology is applied.
AusBiotech supports this finding and reiterates its position presented in its previous submission which recommended that the Act incorporate:
1. Option 4 of the recent OGTR Review of Regulations, which excludes certain new technologies from regulation on the basis of the product and/or outcomes they produce.
2. Redefining Schedule 1, Item 1 of the regulations which currently states:
“Mutant organism in which the mutational event did not involve the introduction of any foreign nucleic acid (that is, non homologous DNA, usually from another species).”
This definition is inconsistent with other definitions within the ‘Act’, such as:
a. gene technology: any technique for the modification of genes or other genetic material;
b. genetically modified organism: an organism that has been modified by gene technology.
There is a need to provide additional definitions around mutagenesis as well as providing consistency in the definitions with other government agencies (e.g. FSANZ). AusBiotech recommends that this be changed to a definition that states:
“A mutant organism in which the mutational event did not involve the introduction of any non-homologous DNA sequences from a non-sexually compatible species.’
3. Exclude ODM, SDN-1 and SDN-2 from regulation under the GT Act 2000 by including these new technologies in Schedule 1A.
4. Exclude cisgenesis from regulation under the GT Act 2000, by including cisgenesis in Schedule 1A.
AusBiotech further supports the OGTR adopting an exemption model for those modifications that are indistinguishable from those made using conventional breeding, natural mutations or mutagenic techniques where:
a) Extensive genetic variations have been introduced by a range of previously available breeding techniques that have historically been accepted without a need for regulation.
b) Plants and animals modified using new technologies should not be differentially regulated if they are similar to, or indistinguishable from, those that could have been produced through earlier breeding methods (i.e. those exempted from regulation under Schedule 1A).
Finding 5 – The Review found that the Scheme was not designed to regulate humans, including those who have received or inherited germline therapies (or who have received somatic therapies that were not envisaged when the Gene Technology Act 2000 was drafted). Therefore, the Scheme is not the most appropriate means to regulate the application of human gene therapies (including any ethical, legal and social issues).
Any consideration of whether additional regulatory oversight is needed in this area may benefit from national collaboration across the health sector, to identify the most appropriate body to undertake this work.
AusBiotech supports this finding. AusBiotech supports The Australian Academy of Technology and Engineering (ATSE’s) view that it is inappropriate for humans to be regulated under the Gene Technology Scheme. Government should consider the NHMRC Embryo Research Licensing Committee as an appropriate body to regulate research that involves human germline modification.
Nevertheless there is no technical impediment to the application of gene technology to humans. For this reason, it is important that the Gene Technology Regulator (GTR) works closely with the regulatory body for human gene technology applications to ensure regulatory consistency and appropriate oversight.
Finding 6 – The Review found that there would be benefit in further work being undertaken to determine the most appropriate approach for regulating the broader environmental release of genetically modified organisms. Subject to administrative and legal considerations, this could include:
• a new licence category with additional requirements specifically relevant to genetically modified biological control agents;
• the application of current risk assessment and risk management approaches and information requirements;
• consideration of the role of the Environment Protection and Biodiversity Conservation Act 1999, the scheme set up by the Biological Control Act 1984 and related state and territory laws, and the intersection of these laws with the Gene Technology Act 2000;
• a new Policy Principle, set of guidelines or code issued by the Legislative and Governance Forum on Gene Technology; and
• other appropriate approaches that may be suggested to achieve the desired outcome (for example, post-release monitoring).
AusBiotech disagrees with this finding and is concerned that this finding could result in additional, scientifically unjustified regulatory burden on the environmental release of GMOs. The current Scheme includes specific risk assessment requirements for organisms to be used in biological control, and these are examined on a case-by-case basis depending on the GMO and its intended use.
Finding 7 – While both contained work and any future environmental releases of genetically modified gene drives should be clearly within the scope of the Scheme, the Review found that there would be benefit in further work being undertaken to determine the most appropriate approach for regulating environmental release of genetically modified gene drive organisms (as well as any additional requirements for contained work). This could include mechanisms similar to those suggested for Finding 6.
AusBiotech agrees that gene drives are GMOs that are within the scope of the current scheme. The current case-by-case approach to risk assessment of the OGTR is sufficiently flexible to assess these types of GMOs.
In both the Australian and international context, the value of having consistent definitions is well understood, as is recognition that definitions have a primary role in the classification of technologies and subsequent regulatory requirements. Any examination of definitions should therefore take into account concurrent work, including the current Technical Review of the Gene Technology Regulations 2001, as well as ongoing work internationally.
AusBiotech supports this finding and would recommend that any proposed changes to definitions consider both regulatory and trade implications as to their use.
Finding 4 – The Review found that synthetic biology is currently within the scope of the Scheme, and there is a high degree of support for this to continue. Work is currently being undertaken by the Australian Council of Learned Academies (ACOLA) which may further inform this issue going forward, including determining the most appropriate mechanism(s) to ensure the appropriate level of regulation of synthetic biology is applied.
AusBiotech supports this finding and reiterates its position presented in its previous submission which recommended that the Act incorporate:
1. Option 4 of the recent OGTR Review of Regulations, which excludes certain new technologies from regulation on the basis of the product and/or outcomes they produce.
2. Redefining Schedule 1, Item 1 of the regulations which currently states:
“Mutant organism in which the mutational event did not involve the introduction of any foreign nucleic acid (that is, non homologous DNA, usually from another species).”
This definition is inconsistent with other definitions within the ‘Act’, such as:
a. gene technology: any technique for the modification of genes or other genetic material;
b. genetically modified organism: an organism that has been modified by gene technology.
There is a need to provide additional definitions around mutagenesis as well as providing consistency in the definitions with other government agencies (e.g. FSANZ). AusBiotech recommends that this be changed to a definition that states:
“A mutant organism in which the mutational event did not involve the introduction of any non-homologous DNA sequences from a non-sexually compatible species.’
3. Exclude ODM, SDN-1 and SDN-2 from regulation under the GT Act 2000 by including these new technologies in Schedule 1A.
4. Exclude cisgenesis from regulation under the GT Act 2000, by including cisgenesis in Schedule 1A.
AusBiotech further supports the OGTR adopting an exemption model for those modifications that are indistinguishable from those made using conventional breeding, natural mutations or mutagenic techniques where:
a) Extensive genetic variations have been introduced by a range of previously available breeding techniques that have historically been accepted without a need for regulation.
b) Plants and animals modified using new technologies should not be differentially regulated if they are similar to, or indistinguishable from, those that could have been produced through earlier breeding methods (i.e. those exempted from regulation under Schedule 1A).
Finding 5 – The Review found that the Scheme was not designed to regulate humans, including those who have received or inherited germline therapies (or who have received somatic therapies that were not envisaged when the Gene Technology Act 2000 was drafted). Therefore, the Scheme is not the most appropriate means to regulate the application of human gene therapies (including any ethical, legal and social issues).
Any consideration of whether additional regulatory oversight is needed in this area may benefit from national collaboration across the health sector, to identify the most appropriate body to undertake this work.
AusBiotech supports this finding. AusBiotech supports The Australian Academy of Technology and Engineering (ATSE’s) view that it is inappropriate for humans to be regulated under the Gene Technology Scheme. Government should consider the NHMRC Embryo Research Licensing Committee as an appropriate body to regulate research that involves human germline modification.
Nevertheless there is no technical impediment to the application of gene technology to humans. For this reason, it is important that the Gene Technology Regulator (GTR) works closely with the regulatory body for human gene technology applications to ensure regulatory consistency and appropriate oversight.
Finding 6 – The Review found that there would be benefit in further work being undertaken to determine the most appropriate approach for regulating the broader environmental release of genetically modified organisms. Subject to administrative and legal considerations, this could include:
• a new licence category with additional requirements specifically relevant to genetically modified biological control agents;
• the application of current risk assessment and risk management approaches and information requirements;
• consideration of the role of the Environment Protection and Biodiversity Conservation Act 1999, the scheme set up by the Biological Control Act 1984 and related state and territory laws, and the intersection of these laws with the Gene Technology Act 2000;
• a new Policy Principle, set of guidelines or code issued by the Legislative and Governance Forum on Gene Technology; and
• other appropriate approaches that may be suggested to achieve the desired outcome (for example, post-release monitoring).
AusBiotech disagrees with this finding and is concerned that this finding could result in additional, scientifically unjustified regulatory burden on the environmental release of GMOs. The current Scheme includes specific risk assessment requirements for organisms to be used in biological control, and these are examined on a case-by-case basis depending on the GMO and its intended use.
Finding 7 – While both contained work and any future environmental releases of genetically modified gene drives should be clearly within the scope of the Scheme, the Review found that there would be benefit in further work being undertaken to determine the most appropriate approach for regulating environmental release of genetically modified gene drive organisms (as well as any additional requirements for contained work). This could include mechanisms similar to those suggested for Finding 6.
AusBiotech agrees that gene drives are GMOs that are within the scope of the current scheme. The current case-by-case approach to risk assessment of the OGTR is sufficiently flexible to assess these types of GMOs.
Findings - Theme 2 - Regulatory Issues
Findings 8 - 15:
Response
Finding 8 – The Review heard strong arguments to support the maintenance of a process-based trigger as the entry point for the Scheme (i.e. a broad range of technologies, including new technologies, are within the scope of the Scheme).
AusBiotech disagrees that a process-based trigger remains an effective entry for the Scheme. The current Scheme is a hybrid of process and product-based regulation. The trigger for regulation is process: an organism is regulated as a GMO where it has been modified by gene technology, unless the gene technology or organism is excluded by the Gene Technology Regulations. The Scheme is “hybrid” insofar as certain products (organisms) are excluded from regulatory oversight based on knowledge of risks posed to the health and safety of people and to the environment and a history of safe use. The risk assessment is also largely based on the characteristics of the organism.
Given the diversity of the regulated community covered by the Scheme, it is unlikely that a solely process based or product based system will be the most appropriate solution for all. For example, a process based approach may be more appropriate for the research community, as indicated by some members of that community (based on submissions for Phase One of this review), but for developers with well characterised products for release into the environment, a greater emphasis on regulation that is product-based is generally favoured.
As noted in the CropLife and AusBiotech submissions for the Technical Review of the Gene Technology Regulations recommended the adoption of Option 4: exclude certain new technologies from regulation on the basis of the outcomes they produce. This option has been interpreted as a product based approach and therefore an outcome beyond the scope of the technical review due to the underlying process based policy setting. Both organisations representing the majority of industry participants responsible for the release of GMOs made specific proposals in their submissions for Phase One of this Review that amounted to minor changes to the Gene Technology Act (definitions of “gene technology” and “genetically modified organism”) and the Gene Technology Regulations (Schedules 1 and 1A) to give effect to Option 4.
These recommendations retain the broad definitions of the Scheme and the process trigger, and add certain exclusions that are both process based (SDN-1, SDN-2, ODM, cisgenesis used in plants) and product based (null segregants) from the scope of regulatory oversight. AusBiotech therefore recommends that the Scheme should combine elements of both a process and product-based system.
Regardless of the regulatory trigger, both process and product based systems need to be defined by appropriate protection goals, be based on appropriate definitions, and contain mechanisms allowing for technology (process) and organism (product) review and exclusions to ensure proportionate risk-based regulation. Exclusion lists should be updated at regular intervals as technology advances and knowledge is gained about technologies and/or organisms. It is also important that the Scheme retains its underlying principles of efficient and effective regulation that is proportionate to risk.
Finding 9 – The Review found that there are opportunities for additional risk tiering to be applied within the Scheme. An additional body of work could be undertaken to determine the most appropriate risk tiers and the types of regulatory requirements assigned to each tier.
Where appropriate, flexibility to move organisms between categories, based on a history of safe use, or the identification of new risks or other relevant factors (see Findings 13 and 14), could be considered. Any changes should aim to ensure the level of regulation remains proportionate with risk and protects against over-regulation or under-regulation.
AusBiotech agrees that there are opportunities for additional risk tiering to be applied within the Scheme. The AusBiotech submission for Phase One of this review included the recommendation for the adoption of a tiered structure for approval of licensed dealings where it has been established and/or demonstrated that proposed licenced dealings are low risk and therefore the requirements and timeframes for assessment could be substantially reduced.
Since the inception of the Scheme there have been a number of advancements such as the use of species biology documents and extensive documentation of the characterisation of various technologies (e.g. RNAi) which have reduced the need for substantial provision of supporting data within an application. These advancements should be reflected in the ability of the GTR to provide approvals where the opportunity exists, for licensed dealings earlier than the minimum statutory time frames within the Scheme. This would be of significant benefit to researchers and the broader industry in the time frame for development and commercialisation of innovation products derived from biotechnology.
Finding 10 – The Review heard that there are a number of opportunities to streamline current regulatory requirements, such as through the introduction of IT and other solutions across a range of areas, including facility certifications, application processes, classification levels, harmonisation of requirements and confidential commercial information assessment timeframes.
AusBiotech agrees there are several opportunities to streamline current regulatory requirements. The AusBiotech submission for Phase One of this review included the following opportunities:
a) A review of the current regulations so that there is clear delineation between the requirements for sexually produced plants and those that are developed through vegetative propagation.
b) A reduction in the regulatory data requirements associated with the deregulation of vegetatively propagated crops (e.g. potato, sugar cane) where the same construct is transformed into different varieties of the same crop. This would remove the need to provide a new deregulation dossier for each new event generated in a different variety with the same construct
c) A tiered approach to the evaluation and assessment of protein safety based on an applicant’s demonstration of the product’s history of safe use. This is important for proteins which are produced at extremely low levels in plants (less than 500 ppb) and cannot be purified in sufficient amounts for biochemical assessments (Bushey et al., 2014). Use a weight-of-evidence approach to evaluate and demonstrate the safety of the protein of interest.
d) The adoption of definitions of ‘gene technology’ and ‘genetically modified organism’ that are consistent between the OGTR and FSANZ.
Finding 11 – The Review heard that changes could be made to enable the GMO Register to be more effectively utilised within the Scheme. In progressing any changes, consideration could be given to whether:
• the requirement for a dealing to have been authorised by a licence before being included on the GMO Register should be removed; and
• an alternative mechanism for adding dealings to the GMO Register should be introduced that is more time and resource efficient, and better reflects the level of risk than the current system requiring a disallowable legislative instrument.
AusBiotech supports this finding that changes could be made to enable the GMO Register to be more effectively utilised within the Scheme.
Finding 12 – The Review heard that there are opportunities for further work to be undertaken to quantify the scope of ‘DIY biology’ activity, ensure that regulatory requirements are widely known, and to further investigate whether current monitoring and enforcement activities are appropriate for all sectors of the Scheme.
AusBiotech supports this finding especially within the context that during the foreseeable future the majority of technologies and products coming within the scope of the Scheme will be derived from SMEs and universities rather than multinational companies. With the recent surge from government and the investment community into agriculture, and in particular into the generation of innovative technologies that will contribute to the increasing demand for food, feed, fibre and energy globally, there is significantly more incentive for researchers to generate an increasing range of technologies that will be covered by the Scheme.
In recent years the progress within the Scheme of a number of products demonstrate this need, with the advancement by SMEs of products such as canola generating Omega 3 oil and safflower generating high oleic oil. The introduction of these products demonstrates that there is a need to not only review current monitoring and enforcement activities but also administrative requirements that are applied to SMEs.
Finding 13 – The Review heard that there is a need for increased flexibility within the Scheme to enable it to appropriately respond to changes in scientific understanding and understandings of risk. Options to increase this flexibility that could be investigated further (subject to administrative and legal considerations) could include:
• enabling the Gene Technology Regulator to make determinations or orders on the applicability of regulation to any technological developments. These determinations (or orders) could be recognised by the Gene Technology Regulations 2001, until such times that they are included in legislation; and
• introducing elements of principles-based regulation to some parts of the Scheme, initially focussing on areas of the Scheme with a history of safe use.
AusBiotech supports this finding. In its Phase One submission AusBiotech suggested the following changes to the Scheme which it believes will allow the GTR the capability and capacity to rapidly adapt the regulatory system to these changes while at the same time continuing to be based on scientific evidence and best-practice regulatory principles. The proposed mechanism would be supported by changes to the time frames for modifications to the Act and/or the Regulations (i.e. reduced to 3 years), both of which currently require significant and unacceptable lead and implementation time frames.
AusBiotech supports the proposed approach of ATSE and the Australian Academy of Science (AAS) to increase the powers and responsibilities of advisory bodies to the GTR. For example, The Gene Technology Technical Advisory Committee (GTTAC) could have a more defined role in advising and making recommendations to the GTR on advancements in gene technology and associated enabling technologies within the context of the current and future legislative and regulatory framework (i.e. do they require regulation or not and if so, do they fall within the current framework or are changes required in regulation and/or legislation).
Similarly, Institutional Biosafety Committees (IBCs) could be provided greater powers in the management of containment facility certification. The OGTR relies heavily on IBCs to provide information and confirmation that physical containment facilities meet the guidelines and requirements of certification. However, the timeframes for new certifications (i.e. 90 working days) are not reasonable and often lead to unnecessary time delays that have direct costs to organisations. To circumvent this, many institutions are submitting partial applications to start the clock to ensure that the certification process does not prevent teaching or research activity. Also, organisations consult extensively with the OGTR during the review period in order to seek expeditious certification. This puts OGTR personnel in awkward situations and under unnecessary pressure.
Following a review of the submissions in Phase One of the review, AusBiotech would support the proposal of CropLife for the Scheme to include a Decision Tree with a Streamlined Risk Assessment (SRA) process for regulated technologies and/or organisms for release into the environment under a licence. This process would not apply where the technology and/or organism is excluded from regulatory scope.
The SRA applies when the following criteria are met:
a) The genetically modified organism (GMO) is well characterised (i.e. an OGTR Ecology and Biology document already exists); OR
b) The genetic modification results in the same or a substantially similar protein and/or substance to one previously approved in Australia; OR
c) The GMO has been approved for cultivation in another country with a ‘recognised’ biosafety regulatory system.
If one or more of those criteria are met, the SRA process features:
a) Reduced data package requirements, with a focus on environmental risk assessment; AND
b) Mandatory consultation only with the states, the GTTAC and the Federal Environment Minister; AND
c) A reduced assessment timeframe commensurate with acknowledgement of lower risk (90 days for a Limited and Controlled Release licence and 120 days for a Commercial Release licence).
This SRA process aims to apply different levels of risk assessment commensurate with risk, and incorporates accumulated scientific knowledge, supported by the early assessments of similar products , along with the familiarity and history of safe use of certain traits and crops. While it was developed for crops for which most knowledge and experience exists for GMOs to be released into the environment, it could also be adapted for other organisms. Existing examples the SRA process could apply to include varieties of insect resistant and herbicide tolerant GM cotton that have been cultivated in Australia for a significant period of time.
Finding 14 – The Review heard that there may be scope to increase the agility of the Scheme, while maintaining appropriate oversight measures. This might include introducing mechanisms to enable certain activities of the Legislative and Governance Forum on Gene Technology to be driven by the Gene Technology Standing Committee.
AusBiotech concurs with the position of CropLife that to date, the Forum has not proven to be an efficient and effective mechanism for oversight and guidance of the Scheme. This is reflected in the lack of action in implementing the recommendations from previous reviews of the Scheme that has resulted in the Scheme failing to keep pace with the technologies it regulates.
Amendments that allow for lowering of the level of regulatory oversight (or risk class) for a given gene technology or class of GMO, e.g. via implementation of the Decision Tree proposed by CropLife (refer Response to Finding 13), or exclude them from regulatory scope, e.g. via exclusions in the Gene Technology Regulations, could be considered by the Forum. All other amendments can be driven by the Gene Technology Standing Committee or progressed directly through federal and state parliamentary processes.
Finding 15 – The Review heard that the Australian government has an important role in coordinating internationally on matters relevant to market access and international trade. There is benefit in the Australian government, including the Gene Technology Regulator on regulatory matters, continuing to engage with appropriate international fora in this area and ensuring that any relevant international obligations continue to be met.
AusBiotech supports this finding. International harmonisation of regulatory regimes promotes the exchange of knowledge and technology resources and provides certainty to researchers, technology providers and organisations engaged in downstream supply chain activities involving trade within and external to countries exporting and importing products derived from biotechnology.
AusBiotech disagrees that a process-based trigger remains an effective entry for the Scheme. The current Scheme is a hybrid of process and product-based regulation. The trigger for regulation is process: an organism is regulated as a GMO where it has been modified by gene technology, unless the gene technology or organism is excluded by the Gene Technology Regulations. The Scheme is “hybrid” insofar as certain products (organisms) are excluded from regulatory oversight based on knowledge of risks posed to the health and safety of people and to the environment and a history of safe use. The risk assessment is also largely based on the characteristics of the organism.
Given the diversity of the regulated community covered by the Scheme, it is unlikely that a solely process based or product based system will be the most appropriate solution for all. For example, a process based approach may be more appropriate for the research community, as indicated by some members of that community (based on submissions for Phase One of this review), but for developers with well characterised products for release into the environment, a greater emphasis on regulation that is product-based is generally favoured.
As noted in the CropLife and AusBiotech submissions for the Technical Review of the Gene Technology Regulations recommended the adoption of Option 4: exclude certain new technologies from regulation on the basis of the outcomes they produce. This option has been interpreted as a product based approach and therefore an outcome beyond the scope of the technical review due to the underlying process based policy setting. Both organisations representing the majority of industry participants responsible for the release of GMOs made specific proposals in their submissions for Phase One of this Review that amounted to minor changes to the Gene Technology Act (definitions of “gene technology” and “genetically modified organism”) and the Gene Technology Regulations (Schedules 1 and 1A) to give effect to Option 4.
These recommendations retain the broad definitions of the Scheme and the process trigger, and add certain exclusions that are both process based (SDN-1, SDN-2, ODM, cisgenesis used in plants) and product based (null segregants) from the scope of regulatory oversight. AusBiotech therefore recommends that the Scheme should combine elements of both a process and product-based system.
Regardless of the regulatory trigger, both process and product based systems need to be defined by appropriate protection goals, be based on appropriate definitions, and contain mechanisms allowing for technology (process) and organism (product) review and exclusions to ensure proportionate risk-based regulation. Exclusion lists should be updated at regular intervals as technology advances and knowledge is gained about technologies and/or organisms. It is also important that the Scheme retains its underlying principles of efficient and effective regulation that is proportionate to risk.
Finding 9 – The Review found that there are opportunities for additional risk tiering to be applied within the Scheme. An additional body of work could be undertaken to determine the most appropriate risk tiers and the types of regulatory requirements assigned to each tier.
Where appropriate, flexibility to move organisms between categories, based on a history of safe use, or the identification of new risks or other relevant factors (see Findings 13 and 14), could be considered. Any changes should aim to ensure the level of regulation remains proportionate with risk and protects against over-regulation or under-regulation.
AusBiotech agrees that there are opportunities for additional risk tiering to be applied within the Scheme. The AusBiotech submission for Phase One of this review included the recommendation for the adoption of a tiered structure for approval of licensed dealings where it has been established and/or demonstrated that proposed licenced dealings are low risk and therefore the requirements and timeframes for assessment could be substantially reduced.
Since the inception of the Scheme there have been a number of advancements such as the use of species biology documents and extensive documentation of the characterisation of various technologies (e.g. RNAi) which have reduced the need for substantial provision of supporting data within an application. These advancements should be reflected in the ability of the GTR to provide approvals where the opportunity exists, for licensed dealings earlier than the minimum statutory time frames within the Scheme. This would be of significant benefit to researchers and the broader industry in the time frame for development and commercialisation of innovation products derived from biotechnology.
Finding 10 – The Review heard that there are a number of opportunities to streamline current regulatory requirements, such as through the introduction of IT and other solutions across a range of areas, including facility certifications, application processes, classification levels, harmonisation of requirements and confidential commercial information assessment timeframes.
AusBiotech agrees there are several opportunities to streamline current regulatory requirements. The AusBiotech submission for Phase One of this review included the following opportunities:
a) A review of the current regulations so that there is clear delineation between the requirements for sexually produced plants and those that are developed through vegetative propagation.
b) A reduction in the regulatory data requirements associated with the deregulation of vegetatively propagated crops (e.g. potato, sugar cane) where the same construct is transformed into different varieties of the same crop. This would remove the need to provide a new deregulation dossier for each new event generated in a different variety with the same construct
c) A tiered approach to the evaluation and assessment of protein safety based on an applicant’s demonstration of the product’s history of safe use. This is important for proteins which are produced at extremely low levels in plants (less than 500 ppb) and cannot be purified in sufficient amounts for biochemical assessments (Bushey et al., 2014). Use a weight-of-evidence approach to evaluate and demonstrate the safety of the protein of interest.
d) The adoption of definitions of ‘gene technology’ and ‘genetically modified organism’ that are consistent between the OGTR and FSANZ.
Finding 11 – The Review heard that changes could be made to enable the GMO Register to be more effectively utilised within the Scheme. In progressing any changes, consideration could be given to whether:
• the requirement for a dealing to have been authorised by a licence before being included on the GMO Register should be removed; and
• an alternative mechanism for adding dealings to the GMO Register should be introduced that is more time and resource efficient, and better reflects the level of risk than the current system requiring a disallowable legislative instrument.
AusBiotech supports this finding that changes could be made to enable the GMO Register to be more effectively utilised within the Scheme.
Finding 12 – The Review heard that there are opportunities for further work to be undertaken to quantify the scope of ‘DIY biology’ activity, ensure that regulatory requirements are widely known, and to further investigate whether current monitoring and enforcement activities are appropriate for all sectors of the Scheme.
AusBiotech supports this finding especially within the context that during the foreseeable future the majority of technologies and products coming within the scope of the Scheme will be derived from SMEs and universities rather than multinational companies. With the recent surge from government and the investment community into agriculture, and in particular into the generation of innovative technologies that will contribute to the increasing demand for food, feed, fibre and energy globally, there is significantly more incentive for researchers to generate an increasing range of technologies that will be covered by the Scheme.
In recent years the progress within the Scheme of a number of products demonstrate this need, with the advancement by SMEs of products such as canola generating Omega 3 oil and safflower generating high oleic oil. The introduction of these products demonstrates that there is a need to not only review current monitoring and enforcement activities but also administrative requirements that are applied to SMEs.
Finding 13 – The Review heard that there is a need for increased flexibility within the Scheme to enable it to appropriately respond to changes in scientific understanding and understandings of risk. Options to increase this flexibility that could be investigated further (subject to administrative and legal considerations) could include:
• enabling the Gene Technology Regulator to make determinations or orders on the applicability of regulation to any technological developments. These determinations (or orders) could be recognised by the Gene Technology Regulations 2001, until such times that they are included in legislation; and
• introducing elements of principles-based regulation to some parts of the Scheme, initially focussing on areas of the Scheme with a history of safe use.
AusBiotech supports this finding. In its Phase One submission AusBiotech suggested the following changes to the Scheme which it believes will allow the GTR the capability and capacity to rapidly adapt the regulatory system to these changes while at the same time continuing to be based on scientific evidence and best-practice regulatory principles. The proposed mechanism would be supported by changes to the time frames for modifications to the Act and/or the Regulations (i.e. reduced to 3 years), both of which currently require significant and unacceptable lead and implementation time frames.
AusBiotech supports the proposed approach of ATSE and the Australian Academy of Science (AAS) to increase the powers and responsibilities of advisory bodies to the GTR. For example, The Gene Technology Technical Advisory Committee (GTTAC) could have a more defined role in advising and making recommendations to the GTR on advancements in gene technology and associated enabling technologies within the context of the current and future legislative and regulatory framework (i.e. do they require regulation or not and if so, do they fall within the current framework or are changes required in regulation and/or legislation).
Similarly, Institutional Biosafety Committees (IBCs) could be provided greater powers in the management of containment facility certification. The OGTR relies heavily on IBCs to provide information and confirmation that physical containment facilities meet the guidelines and requirements of certification. However, the timeframes for new certifications (i.e. 90 working days) are not reasonable and often lead to unnecessary time delays that have direct costs to organisations. To circumvent this, many institutions are submitting partial applications to start the clock to ensure that the certification process does not prevent teaching or research activity. Also, organisations consult extensively with the OGTR during the review period in order to seek expeditious certification. This puts OGTR personnel in awkward situations and under unnecessary pressure.
Following a review of the submissions in Phase One of the review, AusBiotech would support the proposal of CropLife for the Scheme to include a Decision Tree with a Streamlined Risk Assessment (SRA) process for regulated technologies and/or organisms for release into the environment under a licence. This process would not apply where the technology and/or organism is excluded from regulatory scope.
The SRA applies when the following criteria are met:
a) The genetically modified organism (GMO) is well characterised (i.e. an OGTR Ecology and Biology document already exists); OR
b) The genetic modification results in the same or a substantially similar protein and/or substance to one previously approved in Australia; OR
c) The GMO has been approved for cultivation in another country with a ‘recognised’ biosafety regulatory system.
If one or more of those criteria are met, the SRA process features:
a) Reduced data package requirements, with a focus on environmental risk assessment; AND
b) Mandatory consultation only with the states, the GTTAC and the Federal Environment Minister; AND
c) A reduced assessment timeframe commensurate with acknowledgement of lower risk (90 days for a Limited and Controlled Release licence and 120 days for a Commercial Release licence).
This SRA process aims to apply different levels of risk assessment commensurate with risk, and incorporates accumulated scientific knowledge, supported by the early assessments of similar products , along with the familiarity and history of safe use of certain traits and crops. While it was developed for crops for which most knowledge and experience exists for GMOs to be released into the environment, it could also be adapted for other organisms. Existing examples the SRA process could apply to include varieties of insect resistant and herbicide tolerant GM cotton that have been cultivated in Australia for a significant period of time.
Finding 14 – The Review heard that there may be scope to increase the agility of the Scheme, while maintaining appropriate oversight measures. This might include introducing mechanisms to enable certain activities of the Legislative and Governance Forum on Gene Technology to be driven by the Gene Technology Standing Committee.
AusBiotech concurs with the position of CropLife that to date, the Forum has not proven to be an efficient and effective mechanism for oversight and guidance of the Scheme. This is reflected in the lack of action in implementing the recommendations from previous reviews of the Scheme that has resulted in the Scheme failing to keep pace with the technologies it regulates.
Amendments that allow for lowering of the level of regulatory oversight (or risk class) for a given gene technology or class of GMO, e.g. via implementation of the Decision Tree proposed by CropLife (refer Response to Finding 13), or exclude them from regulatory scope, e.g. via exclusions in the Gene Technology Regulations, could be considered by the Forum. All other amendments can be driven by the Gene Technology Standing Committee or progressed directly through federal and state parliamentary processes.
Finding 15 – The Review heard that the Australian government has an important role in coordinating internationally on matters relevant to market access and international trade. There is benefit in the Australian government, including the Gene Technology Regulator on regulatory matters, continuing to engage with appropriate international fora in this area and ensuring that any relevant international obligations continue to be met.
AusBiotech supports this finding. International harmonisation of regulatory regimes promotes the exchange of knowledge and technology resources and provides certainty to researchers, technology providers and organisations engaged in downstream supply chain activities involving trade within and external to countries exporting and importing products derived from biotechnology.
Findings - Theme 3 - Governance Issues
Findings 16 - 28:
Response
Finding 16 – The Review found that the operation of the Scheme has shown to be credible, and that the Scheme operates with integrity and legitimacy as evidenced by:
• high level governance oversight provided by all states and territories through the Legislative and Governance Forum on Gene Technology;
• the independence and credibility of the Gene Technology Regulator; and
• robust governance processes providing oversight of advisory structures and appointments.
AusBiotech supports this finding.
Finding 17 – The Review heard that ensuring national consistency of the Scheme is valued, and that maintaining consistency between all state and territory Acts and the Gene Technology Act 2000 helps provide certainty for stakeholders in relation to current regulatory requirements.
As an aspiration for the Scheme, AusBiotech supports this finding. However, to date this is yet to be achieved despite the time frame that the Scheme has been in place. While there remains inconsistency and lack of continuity between states industry stakeholders and the community will continue to lack confidence in the Scheme and its administration. In addition the lack of consistency between the state, territory and the Federal Government is acting as a disincentive for investment by domestic and international stakeholders in Australian based research and innovation. Addressing this matter is viewed as a key priority for governments.
Finding 18 – The Review found that there are conflicting views among stakeholders regarding the advantages and disadvantages of state and territory moratoria legislation. Further, there is a lack of conclusive evidence on this matter, particularly on the economic effect of moratoria legislation, as economic calculations are context-specific and complex (based on non-stable factors).
AusBiotech strongly rejects this finding. Following the introduction of the first GM crop into Australia in 1996 (Bt cotton) and subsequently herbicide tolerant canola (2008 – Victoria and NSW, 2010 – Western Australia) there has been overwhelming evidence that these technologies have delivered significant benefits to not only Australian farmers, but also to the respective supply chain stakeholders and the community, especially in relation to environmental benefits.
AusBiotech concurs with the view of CropLife that there remains zero evidence to support any trade or marketing advantages of being “GM free”. In contrast, there is ample evidence and data to support the agronomic, environmental and economic benefits that GM crops have provided Australian farmers in the states where they can be grown.
In a recent study released by Dr Scott Biden in which he compared the impact of the moratoriums implemented in Australia on the growing of GM canola when compared to that of the canola industry in Canada where moratoriums on growing GM canola were not introduced, he found the following outcomes:
• The yield impact from the moratoria resulted in an opportunity cost of 1.1 million tonnes of foregone canola production. Pricing this foregone canola production based on the Australian delivered price for canola per metric tonne from 2004-2014, the foregone yield benefit is approximately AU$551 million in lost revenue to the Australian economy.
• The contribution margin, an evaluation of revenue minus the variable costs of production, calculated the per hectare trade-off of GM canola production versus non-GM canola. The impact of the contribution margin indicates a $486 million opportunity cost of foregone producer benefits associated with the moratoria.
• The 4.6 million hectares that would have adopted GM canola, had the moratoriums not been imposed, required an additional 6.5 million of herbicide active ingredients to control weeds. Farmers who use GM seeds end up using lower volumes of herbicides, as weed control is more effective with those seed varieties. The foregone reduction in chemical application resulted in an additional 14.3% environmental impact for Australian consumers, farmworkers and the ecology. Had GM canola not been banned under the moratoriums, farm workers would have been exposed to fewer chemical applications, consumers would have had a reduction in chemical run off exposure and the chemicals applied would have been less toxic.
• In addition to the environmental impact of increased chemical applications, there also is additional fuel used to make those applications, resulting in higher Greenhouse Gas (GHG) emissions. Over 7 million extra machinery passes were made in Australia, burning 8.7 million litres of diesel fuel. Each of these 7 million passes resulted in the needless emission of GHGs due to the moratoriums. As a result, 24,200 metric tons of GHG emissions were emitted, equivalent to approximately 5,000 cars being taken off the road in the USA for one year.
The situation in Australian states is a prime example of how important decisions that affect the competitive future of an entire sector, with far reaching implications for the environment, innovation in agriculture and the state economy, should not be made on political and ideological grounds, but rather on data and facts. Agriculture suffers from chronic underinvestment, both in the development of new crop varieties and in the technologies used to develop them . The Australian Government should recognise that evidence to date has demonstrated that GM crops do not pose any risks to human health and the environment that cannot be identified and managed by the Scheme, and consequently the state and territory moratoria on these crops is anti competitive, hinders investment in R&D, stifles innovation in agriculture, and is in no way commensurate with risk or the underlying principles of the Scheme.
Finding 19 – The Review found that some stakeholders believe that the focus of some moratoria legislation extends beyond marketing purposes, and there may be benefit in further consideration of whether all restrictions (for example, transport restrictions) are appropriate to meet this objective.
AusBiotech agrees with this finding. Currently the continued imposition of the moratorium on transporting GM canola through the state of South Australia by the South Australian Government has resulted in significant increased costs for grains growers in Western Australia and to supply chain participants responsible for the transport of planting seed and grain due to the need to ship seed and grain around the state. This is a significant disincentive to release any new value added GM crops which would be beneficial to Western Australian farmers.
Finding 20 – The Review found that consideration of benefits (e.g. potential economic, environmental and health benefits) should not be introduced at this time as it could risk the effective operation of the Scheme. Consideration of benefits may be an area of ongoing focus in future reviews.
AusBiotech is strongly of the view that consideration of economic and/or social benefits should not be introduced into the Scheme and that it should not be a consideration in any future reviews of the Scheme.
Finding 21 – The Review heard that in order for the potential economic and health benefits of gene technology to be harnessed now and into the future, the Scheme should not impose unnecessary regulatory burdens. The Review found that this may be achieved through regulation that is commensurate with the level of risk posed by a dealing (see Findings 9 and 10).
AusBiotech strongly supports this finding.
Finding 22 – The Review found that there is an opportunity for the Legislative and Governance Forum on Gene Technology (the Forum) to lead a forward work program to consider a range of matters. This may include identifying areas where the Forum could issue Policy Principles, Policy Guidelines and Codes of Practice to provide or clarify policy positions on key matters, noting the responsibility of the Forum to consult and collaborate with other relevant government forums in the conduct of its business. In operationalising a forward work program, the Forum might consider opportunities to leverage the role of the Gene Technology Standing Committee.
AusBiotech disagrees with creating opportunities for the Legislative and Governance Forum on Gene Technology to lead a forward work program.
AusBiotech disagrees with further consideration being given to create new policy principles, unless they are restricted to a purely scientific basis.
Finding 23 – The Review found that consideration could be given to using the current provisions of section 21 of the Gene Technology Act 2000 to enable Policy Principles to be issued on a wider range of topics.
AusBiotech disagrees with further consideration being given to create new policy principles, unless they are restricted to a purely scientific basis.
Finding 24 –The Review heard that there is lack of clarity for some stakeholders regarding the roles of the Office of the Gene Technology Regulator and genetically modified product regulators, which might be addressed through the development of a dedicated gene technology regulation web portal.
AusBiotech supports this finding.
Finding 25 – The Review heard that there may be areas of overlapping regulatory oversight between the Gene Technology Regulator and some product regulators, and that work could be undertaken to investigate potential solutions and any required legislative changes.
AusBiotech strongly supports this finding with priority being given to reducing overlap between the OGTR and FSANZ, together with the AVPMA.
Finding 26 – The Review heard that there are potential mechanisms in other schemes (for example, the Therapeutic Goods Act 1989 Special Access Scheme) that could be adopted to strengthen the Scheme, and there may be benefit in additional investigation being undertaken.
AusBiotech supports this finding and would suggest that this approach be expanded to consider mechanisms employed by regulators in various international jurisdictions.
Finding 27 – The Review heard that full cost recovery may have detrimental effects on the sector (for example, by stifling innovation, impacting international competiveness and eroding trust). This should be taken into account in any work to determine appropriate ongoing funding mechanisms to support the ongoing operation of the Scheme.
AusBiotech supports the view that the implementation of full cost recovery will have detrimental impacts on the sector. In its Phase One submission AusBiotech highlighted its view that the current costs of the processes associated with a stakeholder operating within the Act are reasonable based on the current classes of approval and the compliance approach undertaken by the OGTR within the Act.
Any proposed changes to the current activity that is required by the OGTR to support the scheme will generate unrealistic incremental compliance and associated costs and will be detrimental to current and future investment in introducing new technology to Australia.
AusBiotech is of the view that the OGTR has the opportunity to generate improved operating efficiencies and hence economic efficiency by way of adopting improvements to the current regulatory and compliance model under which it operates.
Finding 28 – The Review found that current funding levels provided for the Gene Technology Regulator’s operational activities may not be sufficient to support future regulatory activities. However, there is scope for additional work to be undertaken to determine appropriate funding levels going forward.
AusBiotech supports this finding.
• high level governance oversight provided by all states and territories through the Legislative and Governance Forum on Gene Technology;
• the independence and credibility of the Gene Technology Regulator; and
• robust governance processes providing oversight of advisory structures and appointments.
AusBiotech supports this finding.
Finding 17 – The Review heard that ensuring national consistency of the Scheme is valued, and that maintaining consistency between all state and territory Acts and the Gene Technology Act 2000 helps provide certainty for stakeholders in relation to current regulatory requirements.
As an aspiration for the Scheme, AusBiotech supports this finding. However, to date this is yet to be achieved despite the time frame that the Scheme has been in place. While there remains inconsistency and lack of continuity between states industry stakeholders and the community will continue to lack confidence in the Scheme and its administration. In addition the lack of consistency between the state, territory and the Federal Government is acting as a disincentive for investment by domestic and international stakeholders in Australian based research and innovation. Addressing this matter is viewed as a key priority for governments.
Finding 18 – The Review found that there are conflicting views among stakeholders regarding the advantages and disadvantages of state and territory moratoria legislation. Further, there is a lack of conclusive evidence on this matter, particularly on the economic effect of moratoria legislation, as economic calculations are context-specific and complex (based on non-stable factors).
AusBiotech strongly rejects this finding. Following the introduction of the first GM crop into Australia in 1996 (Bt cotton) and subsequently herbicide tolerant canola (2008 – Victoria and NSW, 2010 – Western Australia) there has been overwhelming evidence that these technologies have delivered significant benefits to not only Australian farmers, but also to the respective supply chain stakeholders and the community, especially in relation to environmental benefits.
AusBiotech concurs with the view of CropLife that there remains zero evidence to support any trade or marketing advantages of being “GM free”. In contrast, there is ample evidence and data to support the agronomic, environmental and economic benefits that GM crops have provided Australian farmers in the states where they can be grown.
In a recent study released by Dr Scott Biden in which he compared the impact of the moratoriums implemented in Australia on the growing of GM canola when compared to that of the canola industry in Canada where moratoriums on growing GM canola were not introduced, he found the following outcomes:
• The yield impact from the moratoria resulted in an opportunity cost of 1.1 million tonnes of foregone canola production. Pricing this foregone canola production based on the Australian delivered price for canola per metric tonne from 2004-2014, the foregone yield benefit is approximately AU$551 million in lost revenue to the Australian economy.
• The contribution margin, an evaluation of revenue minus the variable costs of production, calculated the per hectare trade-off of GM canola production versus non-GM canola. The impact of the contribution margin indicates a $486 million opportunity cost of foregone producer benefits associated with the moratoria.
• The 4.6 million hectares that would have adopted GM canola, had the moratoriums not been imposed, required an additional 6.5 million of herbicide active ingredients to control weeds. Farmers who use GM seeds end up using lower volumes of herbicides, as weed control is more effective with those seed varieties. The foregone reduction in chemical application resulted in an additional 14.3% environmental impact for Australian consumers, farmworkers and the ecology. Had GM canola not been banned under the moratoriums, farm workers would have been exposed to fewer chemical applications, consumers would have had a reduction in chemical run off exposure and the chemicals applied would have been less toxic.
• In addition to the environmental impact of increased chemical applications, there also is additional fuel used to make those applications, resulting in higher Greenhouse Gas (GHG) emissions. Over 7 million extra machinery passes were made in Australia, burning 8.7 million litres of diesel fuel. Each of these 7 million passes resulted in the needless emission of GHGs due to the moratoriums. As a result, 24,200 metric tons of GHG emissions were emitted, equivalent to approximately 5,000 cars being taken off the road in the USA for one year.
The situation in Australian states is a prime example of how important decisions that affect the competitive future of an entire sector, with far reaching implications for the environment, innovation in agriculture and the state economy, should not be made on political and ideological grounds, but rather on data and facts. Agriculture suffers from chronic underinvestment, both in the development of new crop varieties and in the technologies used to develop them . The Australian Government should recognise that evidence to date has demonstrated that GM crops do not pose any risks to human health and the environment that cannot be identified and managed by the Scheme, and consequently the state and territory moratoria on these crops is anti competitive, hinders investment in R&D, stifles innovation in agriculture, and is in no way commensurate with risk or the underlying principles of the Scheme.
Finding 19 – The Review found that some stakeholders believe that the focus of some moratoria legislation extends beyond marketing purposes, and there may be benefit in further consideration of whether all restrictions (for example, transport restrictions) are appropriate to meet this objective.
AusBiotech agrees with this finding. Currently the continued imposition of the moratorium on transporting GM canola through the state of South Australia by the South Australian Government has resulted in significant increased costs for grains growers in Western Australia and to supply chain participants responsible for the transport of planting seed and grain due to the need to ship seed and grain around the state. This is a significant disincentive to release any new value added GM crops which would be beneficial to Western Australian farmers.
Finding 20 – The Review found that consideration of benefits (e.g. potential economic, environmental and health benefits) should not be introduced at this time as it could risk the effective operation of the Scheme. Consideration of benefits may be an area of ongoing focus in future reviews.
AusBiotech is strongly of the view that consideration of economic and/or social benefits should not be introduced into the Scheme and that it should not be a consideration in any future reviews of the Scheme.
Finding 21 – The Review heard that in order for the potential economic and health benefits of gene technology to be harnessed now and into the future, the Scheme should not impose unnecessary regulatory burdens. The Review found that this may be achieved through regulation that is commensurate with the level of risk posed by a dealing (see Findings 9 and 10).
AusBiotech strongly supports this finding.
Finding 22 – The Review found that there is an opportunity for the Legislative and Governance Forum on Gene Technology (the Forum) to lead a forward work program to consider a range of matters. This may include identifying areas where the Forum could issue Policy Principles, Policy Guidelines and Codes of Practice to provide or clarify policy positions on key matters, noting the responsibility of the Forum to consult and collaborate with other relevant government forums in the conduct of its business. In operationalising a forward work program, the Forum might consider opportunities to leverage the role of the Gene Technology Standing Committee.
AusBiotech disagrees with creating opportunities for the Legislative and Governance Forum on Gene Technology to lead a forward work program.
AusBiotech disagrees with further consideration being given to create new policy principles, unless they are restricted to a purely scientific basis.
Finding 23 – The Review found that consideration could be given to using the current provisions of section 21 of the Gene Technology Act 2000 to enable Policy Principles to be issued on a wider range of topics.
AusBiotech disagrees with further consideration being given to create new policy principles, unless they are restricted to a purely scientific basis.
Finding 24 –The Review heard that there is lack of clarity for some stakeholders regarding the roles of the Office of the Gene Technology Regulator and genetically modified product regulators, which might be addressed through the development of a dedicated gene technology regulation web portal.
AusBiotech supports this finding.
Finding 25 – The Review heard that there may be areas of overlapping regulatory oversight between the Gene Technology Regulator and some product regulators, and that work could be undertaken to investigate potential solutions and any required legislative changes.
AusBiotech strongly supports this finding with priority being given to reducing overlap between the OGTR and FSANZ, together with the AVPMA.
Finding 26 – The Review heard that there are potential mechanisms in other schemes (for example, the Therapeutic Goods Act 1989 Special Access Scheme) that could be adopted to strengthen the Scheme, and there may be benefit in additional investigation being undertaken.
AusBiotech supports this finding and would suggest that this approach be expanded to consider mechanisms employed by regulators in various international jurisdictions.
Finding 27 – The Review heard that full cost recovery may have detrimental effects on the sector (for example, by stifling innovation, impacting international competiveness and eroding trust). This should be taken into account in any work to determine appropriate ongoing funding mechanisms to support the ongoing operation of the Scheme.
AusBiotech supports the view that the implementation of full cost recovery will have detrimental impacts on the sector. In its Phase One submission AusBiotech highlighted its view that the current costs of the processes associated with a stakeholder operating within the Act are reasonable based on the current classes of approval and the compliance approach undertaken by the OGTR within the Act.
Any proposed changes to the current activity that is required by the OGTR to support the scheme will generate unrealistic incremental compliance and associated costs and will be detrimental to current and future investment in introducing new technology to Australia.
AusBiotech is of the view that the OGTR has the opportunity to generate improved operating efficiencies and hence economic efficiency by way of adopting improvements to the current regulatory and compliance model under which it operates.
Finding 28 – The Review found that current funding levels provided for the Gene Technology Regulator’s operational activities may not be sufficient to support future regulatory activities. However, there is scope for additional work to be undertaken to determine appropriate funding levels going forward.
AusBiotech supports this finding.
Findings - Theme 4 - Social and Ethical Issues
Findings 29 to 33:
Response
Finding 29 – The Review heard that public understanding and confidence in the Scheme may be aided by additional communication mechanisms (building on existing bodies of work). There may be benefit in additional work to determine the most appropriate body to lead communication activities. Any additional communication activities would need to be appropriately funded.
AusBiotech supports this finding and would suggest that it be part of a broader program that promotes the role of various regulators that impact on the community and the agriculture industry (e.g. FSANZ and AVPMA).
Finding 30 – The Review heard that it is appropriate for the Gene Technology Regulator to continue to lead communication activities on topics related to the assessment of risk associated with gene technology.
AusBiotech supports this finding.
Finding 31 – The Review found that despite current regulatory arrangements, there remain ongoing concerns within some sections of the community about the safety of genetically modified organisms, and in particular the safety of genetically modified foods.
AusBiotech supports this finding. Along with CropLife, AusBiotech believes there is the opportunity for the Government to re-launch the agency Biotechnology Australia, that existed within the Department of Industry from 1999 to ~2010. There is also the opportunity for a revised and refreshed National Biotechnology Strategy to build on the Strategy first outlined in 2000 and map the way forward for biotechnology policy in Australia.
Finding 32 –The Review heard that there may be benefit in additional consideration being given to whether current post-release review mechanisms are sufficient, whether additional public communication of activities undertaken is required to increase transparency, and whether mechanisms and resourcing for the Gene Technology Regulator to undertake additional surveillance activities are required.
AusBiotech agrees with this finding in principle, providing that any additional communication of information is limited to activities that are required under the final Risk Assessment, which is limited to human health safety and the environment.
Finding 33 – The Review found that a high level of transparency and public access to information can be achieved through the Gene Technology Regulator continuing to make relevant information publicly available, and through increased communication with the public (see Findings 29 and 30).
AusBiotech supports this finding, however cautions that there needs to be a balance between what is required for the purpose of regulatory transparency and information is required to be protected so as to ensure applicant’s intellectual property rights are retained.
AusBiotech supports this finding and would suggest that it be part of a broader program that promotes the role of various regulators that impact on the community and the agriculture industry (e.g. FSANZ and AVPMA).
Finding 30 – The Review heard that it is appropriate for the Gene Technology Regulator to continue to lead communication activities on topics related to the assessment of risk associated with gene technology.
AusBiotech supports this finding.
Finding 31 – The Review found that despite current regulatory arrangements, there remain ongoing concerns within some sections of the community about the safety of genetically modified organisms, and in particular the safety of genetically modified foods.
AusBiotech supports this finding. Along with CropLife, AusBiotech believes there is the opportunity for the Government to re-launch the agency Biotechnology Australia, that existed within the Department of Industry from 1999 to ~2010. There is also the opportunity for a revised and refreshed National Biotechnology Strategy to build on the Strategy first outlined in 2000 and map the way forward for biotechnology policy in Australia.
Finding 32 –The Review heard that there may be benefit in additional consideration being given to whether current post-release review mechanisms are sufficient, whether additional public communication of activities undertaken is required to increase transparency, and whether mechanisms and resourcing for the Gene Technology Regulator to undertake additional surveillance activities are required.
AusBiotech agrees with this finding in principle, providing that any additional communication of information is limited to activities that are required under the final Risk Assessment, which is limited to human health safety and the environment.
Finding 33 – The Review found that a high level of transparency and public access to information can be achieved through the Gene Technology Regulator continuing to make relevant information publicly available, and through increased communication with the public (see Findings 29 and 30).
AusBiotech supports this finding, however cautions that there needs to be a balance between what is required for the purpose of regulatory transparency and information is required to be protected so as to ensure applicant’s intellectual property rights are retained.