Introduction
Are you providing a submission as a representative of an organisation?
If yes, what is the name of your organisation?
Corteva Agriscience, the Agriculture Division of DowDuPont
Findings - Theme 1 - Technical Issues
Findings 3 to 7:
Response
Finding 3. Classification of new technologies
Corteva Agriscience agrees that the existing definitions in the Gene Technology Act 2000 and Gene Technology Regulations 2001 do not appropriately classify the advances in technology, with specific reference to the definitions of ‘gene technology’ and ‘genetically modified organism.’ Corteva Agriscience as a part of submissions to the 2016-2017 Technical Review of the Gene Technology Regulations 2001 to the Office of the Gene Technology Regulator (OGTR), the Review of the National Gene Technology Scheme and the Food Standards Australia New Zealand (FSANZ) Consultation Paper – Food Derived Using New Technologies has proposed the following revision to the definitions. Alignment across these areas of regulation with respect to the definitions will provide consistency and clarity for all concerned with adoption of these proposed definitions also future-proofing the aforementioned regulations with regards to advancement in technology, while protecting health and the environment but also supporting innovation.
Gene Technology means any technique for the modification of genes or other genetic material, but does not include:
(a) Sexual reproduction; or
(b) Homologous recombination; or
(c) Techniques that result in a modified organism where such modification could also occur in nature or be obtained using conventional breeding
genetically modified organism means:
(a) an organism that has been modified by gene technology; or
(b) an organism that has inherited particular traits from an organism (the initial organism), being traits that occurred in the initial organism because of gene technology; or
(c) anything declared by the regulations to be a genetically modified organism, or that belongs to a class of things declared by the regulations to be genetically modified organisms;
but does not include:
(d) a human being, if the human being is covered by paragraph (a) only because the human being has undergone somatic cell gene therapy; or
(e) an organism that has not inherited genes or other genetic material from an organism (the initial organism) that occurred in the initial organism because of gene technology;
(f) an organism declared by the regulations not to be a genetically modified organism, or that belongs to a class of organisms declared by the regulations not to be genetically modified organisms.
Finding 4. Emerging applications: Synthetic biology
With respect to Synthetic biology, it is important to note, that there is yet no international consensus on a meaningful, broadly applicable, and future-proof definition of synthetic biology. This term builds on a range of existing biotechnological tools and is part of the continuum of development of modern biotechnology. Synthetic biology is often attempted to be described though the range of tools, such as recombinant DNA technology (gene cloning), accelerated DNA synthesis, CRISPR, etc., which can be misleading (1). Corteva Agriscience believes that the tool (or tools) themselves do not define if the resulted organism is a synthetic biology organism or not. For example, all current commercial crops developed with the use of recombinant DNA technology are GMO crops, not “synthetic biology crops”. As we have commented previously (2,3), CRISPR-Cas gene editing generates organisms that could have been similarly produced through conventional breeding or found in nature, and in our opinion, should not be categorized as GMOs, let alone the synthetic biology organisms. As such, we recommend that the existing principle of a case by case basis of risk assessment as employed by the OGTR is maintained for synthetic biology applications within Australia.
Finding 5. Emerging applications: Human germline gene therapy
Corteva Agriscience agrees that human germline therapy is not within the scope of the Scheme and should remain as thus.
Finding 6. Intentional environmental release: Biological control
Corteva Agriscience disagrees that there is a need to regulate the broader environmental release of all GMOs. Specifically, we disagree with the necessity of the proposed concept of post-release monitoring for GM crops in addition to existing requirements. The OGTR through their administration of the Act, ensure that any risk is considered prior to commercial release through the Risk Assessment process and the Risk Management Plan. Existing post-market licence reporting requirements, reporting of unintended effects and new relevant scientific information sufficiently address the potential for further risk. GM crops derived from established techniques of genetic modification have been commercially cultivated since 1996 without unexpected negative effects on ecosystems or adverse effects on human or animal health. As predicted by scientists early on, these GM crops have posed no unique or incremental risks different from those posed by crop varieties produced through conventional breeding techniques, including mutagenesis.
Finding 7. Emerging applications: Gene Drives
On the provision that that Finding 7 relates solely to gene drives, Corteva Agriscience agrees with this finding. As outlined in our response to Finding 6, we do not support the implementation of additional post-release monitoring for all GMOs, specifically GM crops, and would counsel the same to be considered here.
1 https://ec.europa.eu/health/scientific_committees/emerging/docs/scenihr_o_044.pdf
2 https://consultations.health.gov.au/best-practice-regulation/review-of-national-gene-technology-scheme/consultation/view_respondent?uuId=336018842
3 http://www.health.gov.au/internet/main/publishing.nsf/Content/C28DC671DFEB6FDBCA2581CF00775388/$File/DuPont%20Pioneer.pdf
Corteva Agriscience agrees that the existing definitions in the Gene Technology Act 2000 and Gene Technology Regulations 2001 do not appropriately classify the advances in technology, with specific reference to the definitions of ‘gene technology’ and ‘genetically modified organism.’ Corteva Agriscience as a part of submissions to the 2016-2017 Technical Review of the Gene Technology Regulations 2001 to the Office of the Gene Technology Regulator (OGTR), the Review of the National Gene Technology Scheme and the Food Standards Australia New Zealand (FSANZ) Consultation Paper – Food Derived Using New Technologies has proposed the following revision to the definitions. Alignment across these areas of regulation with respect to the definitions will provide consistency and clarity for all concerned with adoption of these proposed definitions also future-proofing the aforementioned regulations with regards to advancement in technology, while protecting health and the environment but also supporting innovation.
Gene Technology means any technique for the modification of genes or other genetic material, but does not include:
(a) Sexual reproduction; or
(b) Homologous recombination; or
(c) Techniques that result in a modified organism where such modification could also occur in nature or be obtained using conventional breeding
genetically modified organism means:
(a) an organism that has been modified by gene technology; or
(b) an organism that has inherited particular traits from an organism (the initial organism), being traits that occurred in the initial organism because of gene technology; or
(c) anything declared by the regulations to be a genetically modified organism, or that belongs to a class of things declared by the regulations to be genetically modified organisms;
but does not include:
(d) a human being, if the human being is covered by paragraph (a) only because the human being has undergone somatic cell gene therapy; or
(e) an organism that has not inherited genes or other genetic material from an organism (the initial organism) that occurred in the initial organism because of gene technology;
(f) an organism declared by the regulations not to be a genetically modified organism, or that belongs to a class of organisms declared by the regulations not to be genetically modified organisms.
Finding 4. Emerging applications: Synthetic biology
With respect to Synthetic biology, it is important to note, that there is yet no international consensus on a meaningful, broadly applicable, and future-proof definition of synthetic biology. This term builds on a range of existing biotechnological tools and is part of the continuum of development of modern biotechnology. Synthetic biology is often attempted to be described though the range of tools, such as recombinant DNA technology (gene cloning), accelerated DNA synthesis, CRISPR, etc., which can be misleading (1). Corteva Agriscience believes that the tool (or tools) themselves do not define if the resulted organism is a synthetic biology organism or not. For example, all current commercial crops developed with the use of recombinant DNA technology are GMO crops, not “synthetic biology crops”. As we have commented previously (2,3), CRISPR-Cas gene editing generates organisms that could have been similarly produced through conventional breeding or found in nature, and in our opinion, should not be categorized as GMOs, let alone the synthetic biology organisms. As such, we recommend that the existing principle of a case by case basis of risk assessment as employed by the OGTR is maintained for synthetic biology applications within Australia.
Finding 5. Emerging applications: Human germline gene therapy
Corteva Agriscience agrees that human germline therapy is not within the scope of the Scheme and should remain as thus.
Finding 6. Intentional environmental release: Biological control
Corteva Agriscience disagrees that there is a need to regulate the broader environmental release of all GMOs. Specifically, we disagree with the necessity of the proposed concept of post-release monitoring for GM crops in addition to existing requirements. The OGTR through their administration of the Act, ensure that any risk is considered prior to commercial release through the Risk Assessment process and the Risk Management Plan. Existing post-market licence reporting requirements, reporting of unintended effects and new relevant scientific information sufficiently address the potential for further risk. GM crops derived from established techniques of genetic modification have been commercially cultivated since 1996 without unexpected negative effects on ecosystems or adverse effects on human or animal health. As predicted by scientists early on, these GM crops have posed no unique or incremental risks different from those posed by crop varieties produced through conventional breeding techniques, including mutagenesis.
Finding 7. Emerging applications: Gene Drives
On the provision that that Finding 7 relates solely to gene drives, Corteva Agriscience agrees with this finding. As outlined in our response to Finding 6, we do not support the implementation of additional post-release monitoring for all GMOs, specifically GM crops, and would counsel the same to be considered here.
1 https://ec.europa.eu/health/scientific_committees/emerging/docs/scenihr_o_044.pdf
2 https://consultations.health.gov.au/best-practice-regulation/review-of-national-gene-technology-scheme/consultation/view_respondent?uuId=336018842
3 http://www.health.gov.au/internet/main/publishing.nsf/Content/C28DC671DFEB6FDBCA2581CF00775388/$File/DuPont%20Pioneer.pdf
Findings - Theme 2 - Regulatory Issues
Findings 8 - 15:
Response
Finding 8. Regulatory triggers
The science of gene technology is continuously evolving and continues to contribute to addressing the challenges faced globally with regards to food security, population growth and sustainability. The practical implementation of such technological advances is however heavily influenced by whether or not the regulatory environment manages these advances in a manner commensurate with potential risks of their products. Corteva Agriscience considers it essential that risks are identified and managed with regards to human health, safety and the environment, and that any regulatory regime should be focused on the potential risks of a particular product regardless of the process used to develop it, whilst supporting innovation. It is the characteristics of the resulting organism, and not the method by which it was produced, that determines its safety. The long history of safe use of plant varieties produced through domestication and conventional breeding demonstrates that the specific techniques used to develop them do not pose an inherent safety risk. If an end product cannot be distinguished from a product that could be produced using methods that are not regulated as gene technology, regulation would be both inefficient, over-burdensome, and inappropriate. In a consistent and predictable regulatory environment, products indistinguishable from those that could occur in nature or derive by traditional breeding methods should be held to the same regulatory standards.
To facilitate the delivery of an agile and effective Scheme, now and into the future, both those who are regulated under the Scheme and the triggers by which regulation occurs, need to be considered. Currently the scheme relies heavily on regulatory triggers focused on the process, that is, an organism is regulated as a GMO if it has been modified by gene technology and is not excluded by the Gene Technology Regulations. The Scheme is not limited to the process-based triggers via the use of exclusions under the Gene Technology Regulations 2001. However, the existing process is limiting to the development of new technologies such as site directed nucleases (SDN) and oligonucleotide-directed mutagenesis (ODM).
Looking ahead to the future, and in consideration of the diverse nature of the regulated community, we suggest that the Scheme gives further consideration to the proposed new definitions of gene technology and GMOs, as outline in our response to Finding 3. Implementation of these definitions would enable the OGTR to implement the original Option 4, as provided in their Technical Review of the Gene Technology Act. This Option proposed to exclude certain new technologies from regulation on the basis of the outcomes they produce. Such an approach would future-proof the Scheme in line with innovation and technological developments.
Finding 9. Risk tiering and appropriate regulation of environmental releases
Corteva Agriscience agrees that there are opportunities for additional risk tiering to be applied within the scheme. We support a future Scheme that manages risk based regulation by considering the risks posed by the resulting organism.
Finding 10. Streamlining regulation
Corteva Agriscience agrees that there is opportunity to streamline regulatory requirements through the introduction of IT and other solutions. As outlined in our response to Finding 8, we believe that there are opportunities to future-proof and increase the efficiency of the Scheme. Furthermore, as per our response to Findings 24, 25 and 26, opportunities exist for coordination and streamlining amongst the Australian regulators who participate in the regulation of GMOs.
Finding 11. Operation of the GMO Register
Corteva Agriscience supports the proposal to enable the GMO Register to be effectively utilised within the scheme.
Finding 12. Accessibility and managing new potential harms
Corteva Agriscience supports the need for regulation to be commensurate with the level of risk. With respect to DIY biology activities, the same level of regulation ought to be applied if the same level of risk if comparable to other regulated dealings.
Findings 13 and 14. Future-proofing regulation and principles based regulation
Corteva Agriscience agrees that there is a need for increased flexibility within the Scheme, enabling it to respond to innovation in a future-proofed manner. The existing process potentially limits the development of new technologies such as SDN and ODM. Looking ahead, as outlined in our response to Finding 8, we suggest that the Scheme considers revision of key definitions enabling Regulations to adapt to innovation and technological developments. Furthermore this would advance the Scheme to a stage where current innovations such as SDN-1, SDN-2, ODM and null segregants would be excluded from regulatory scope. Such a development is consistent with the scientific tenet that if the final organism cannot be distinguished from an organism that is produced using methods not regulated as gene technology, they should be held to the same regulatory standards.
Finding 15. Market access and international trade
Corteva Agriscience agrees that the Australian government has an important role in working with the Gene Technology Regulator, supporting matters relevant to market access and international trade, ensuring obligations are being met, but while also supporting innovation.
The science of gene technology is continuously evolving and continues to contribute to addressing the challenges faced globally with regards to food security, population growth and sustainability. The practical implementation of such technological advances is however heavily influenced by whether or not the regulatory environment manages these advances in a manner commensurate with potential risks of their products. Corteva Agriscience considers it essential that risks are identified and managed with regards to human health, safety and the environment, and that any regulatory regime should be focused on the potential risks of a particular product regardless of the process used to develop it, whilst supporting innovation. It is the characteristics of the resulting organism, and not the method by which it was produced, that determines its safety. The long history of safe use of plant varieties produced through domestication and conventional breeding demonstrates that the specific techniques used to develop them do not pose an inherent safety risk. If an end product cannot be distinguished from a product that could be produced using methods that are not regulated as gene technology, regulation would be both inefficient, over-burdensome, and inappropriate. In a consistent and predictable regulatory environment, products indistinguishable from those that could occur in nature or derive by traditional breeding methods should be held to the same regulatory standards.
To facilitate the delivery of an agile and effective Scheme, now and into the future, both those who are regulated under the Scheme and the triggers by which regulation occurs, need to be considered. Currently the scheme relies heavily on regulatory triggers focused on the process, that is, an organism is regulated as a GMO if it has been modified by gene technology and is not excluded by the Gene Technology Regulations. The Scheme is not limited to the process-based triggers via the use of exclusions under the Gene Technology Regulations 2001. However, the existing process is limiting to the development of new technologies such as site directed nucleases (SDN) and oligonucleotide-directed mutagenesis (ODM).
Looking ahead to the future, and in consideration of the diverse nature of the regulated community, we suggest that the Scheme gives further consideration to the proposed new definitions of gene technology and GMOs, as outline in our response to Finding 3. Implementation of these definitions would enable the OGTR to implement the original Option 4, as provided in their Technical Review of the Gene Technology Act. This Option proposed to exclude certain new technologies from regulation on the basis of the outcomes they produce. Such an approach would future-proof the Scheme in line with innovation and technological developments.
Finding 9. Risk tiering and appropriate regulation of environmental releases
Corteva Agriscience agrees that there are opportunities for additional risk tiering to be applied within the scheme. We support a future Scheme that manages risk based regulation by considering the risks posed by the resulting organism.
Finding 10. Streamlining regulation
Corteva Agriscience agrees that there is opportunity to streamline regulatory requirements through the introduction of IT and other solutions. As outlined in our response to Finding 8, we believe that there are opportunities to future-proof and increase the efficiency of the Scheme. Furthermore, as per our response to Findings 24, 25 and 26, opportunities exist for coordination and streamlining amongst the Australian regulators who participate in the regulation of GMOs.
Finding 11. Operation of the GMO Register
Corteva Agriscience supports the proposal to enable the GMO Register to be effectively utilised within the scheme.
Finding 12. Accessibility and managing new potential harms
Corteva Agriscience supports the need for regulation to be commensurate with the level of risk. With respect to DIY biology activities, the same level of regulation ought to be applied if the same level of risk if comparable to other regulated dealings.
Findings 13 and 14. Future-proofing regulation and principles based regulation
Corteva Agriscience agrees that there is a need for increased flexibility within the Scheme, enabling it to respond to innovation in a future-proofed manner. The existing process potentially limits the development of new technologies such as SDN and ODM. Looking ahead, as outlined in our response to Finding 8, we suggest that the Scheme considers revision of key definitions enabling Regulations to adapt to innovation and technological developments. Furthermore this would advance the Scheme to a stage where current innovations such as SDN-1, SDN-2, ODM and null segregants would be excluded from regulatory scope. Such a development is consistent with the scientific tenet that if the final organism cannot be distinguished from an organism that is produced using methods not regulated as gene technology, they should be held to the same regulatory standards.
Finding 15. Market access and international trade
Corteva Agriscience agrees that the Australian government has an important role in working with the Gene Technology Regulator, supporting matters relevant to market access and international trade, ensuring obligations are being met, but while also supporting innovation.
Findings - Theme 3 - Governance Issues
Findings 16 - 28:
Response
Finding 16. Credibility, integrity and legitimacy of the Scheme
Corteva Agriscience agrees that the Scheme has shown to be credible and operates with integrity and legitimacy.
Finding 17. National consistency of the Scheme Governance
Corteva Agriscience agrees that national consistency of the Scheme is valued and consistency across state, territory and Commonwealth legislation is required for certainty in relation to regulatory requirements.
Findings 18 and 19. Adaptability, flexibility and national consistency of the Scheme: Moratoria legislation
Corteva Agriscience is of the opinion that state and territory moratoria legislation do not positively benefit Australia as per Finding 18, and with respect to Finding 19, believes their focus extends beyond marketing purposes. These opinions are supported by the Australian Bureau of Agricultural Resource Economics (ABARE) reports from 2005 (4) and 2008 (5) . The 2005 report showed that Australia’s canola growers were negatively impacted by the presence of state moratorium against genetically modified canola with potential losses of $3 billion in net present value terms in the period to 2015. This forecast is further supported by the 2008 ABARE report which showed the estimated economic benefit to Western Australia from adopting GM canola from 2008-09 for the following ten years would be $180 million in 2006-07 dollars. For New South Wales’ farmers (excluding those in the Murray Catchment Area) the benefit was estimated to be $273 million and South Australian farmers would receive a benefit of $115 million. Similarly, an academic study estimated that the GM canola moratoria in Australia cost farmers nearly $500 million in lost revenue (6). Such data is further supported by more recent independent market analysis by Mecardo (7) , in 2016 and 2017 which showed there is little evidence to determine that South Australia has achieved a premium for its non-GM canola crop due to the moratorium on GM technology. Comparing the difference between non-GM canola in Adelaide (SA) and Kwinana (WA) demonstrated a clear premium for non-GM canola in Kwinana throughout the entire season. There is even evidence of GM canola in Kwinana achieving a premium over Adelaide non-GM.
This data shows that state and territory based moratoria are negatively impacting Australian farmers and claims that perpetrate the need to maintain moratoria for marketing purposes are not valid.
Finding 20. Harnessing the economic and health benefits of gene technology: Benefit consideration
Corteva Agriscience proposes that the consideration of comparative benefits should not be excluded from regulatory decision-making but rather be scientifically based and used in consideration of innovation and technological developments. Such information may also assist public understanding and confidence in the Gene Technology Scheme.
Finding 21. Harnessing the economic and health benefits of gene technology: Regulatory burden
Corteva Agriscience agrees that regulation should always be commensurate with risk and not imposing undue regulatory burden which could stall the adoption of new technological advancements, both in Australia and globally.
Findings 22 and 23. Clarity on policy considerations of the Scheme
With respect to Finding 22, Corteva Agriscience supports the proposal that an opportunity exists for improved regulatory and policy clarity. Corteva Agriscience™ does not support the proposal of Finding 23 with respect to Schedule 21, specifically Schedule 21 (1) (aa) of the existing Scheme. As outlined in our response to Findings 18 and 19, we do not believe the claim for state or territory moratoria holds validity and rather suggest that the Review considers a repeal of Schedule 21 from the Scheme.
Findings 24, 25 and 26. Coordination with other regulators
Corteva Agriscience supports the proposal as per Finding 24, that a dedicated gene technology regulation web portal be developed.
We also concur that currently there is duplication of regulation as per Finding 25. Currently there is overlap between the OGTR, FSANZ and the Australian Pesticides and Veterinary Medicines Authority (APVMA) for products regulated as GMOs. To reduce this unnecessary duplication, time delays and costs, we recommend acceptance of risk assessments from the OGTR and FSANZ by APVMA or alternatively, remove the regulatory responsibility for GM products with incorporated pest and/or disease control by the APVMA.
With respect to Finding 26, Corteva Agriscience requests further clarity to be provided on such a proposal prior to providing comment.
Findings 27 and 28. Funding model
Corteva Agriscience agrees with Findings 27 and 28 with respect to full cost recovery and current funding levels.
4 Apted S., McDonald D., Rodgers H., 2005, Transgenic Crops: Welfare implications for Australia ABARE Australian Commodities, vol. 12, no. 3
5 Acworth, W., Yainshet., A, Curtotti, R, 2008 Economic impacts of GM crops in Australia ABARE Research Report 2008
6 Smyth, SJ (2017) Genetically Modified Crops, Regulatory Delays, and International Trade. Food and Energy Security 6:78-86.
7 Whitelaw A (2016) ‘Is the GM ban in South Australia providing a premium?’ Mercado Expert Market Analysis: 25 July 2016; and Whitelaw A (2017) ‘Controversial canola’. Mercado Expert Analysis: May 25 2017.
Corteva Agriscience agrees that the Scheme has shown to be credible and operates with integrity and legitimacy.
Finding 17. National consistency of the Scheme Governance
Corteva Agriscience agrees that national consistency of the Scheme is valued and consistency across state, territory and Commonwealth legislation is required for certainty in relation to regulatory requirements.
Findings 18 and 19. Adaptability, flexibility and national consistency of the Scheme: Moratoria legislation
Corteva Agriscience is of the opinion that state and territory moratoria legislation do not positively benefit Australia as per Finding 18, and with respect to Finding 19, believes their focus extends beyond marketing purposes. These opinions are supported by the Australian Bureau of Agricultural Resource Economics (ABARE) reports from 2005 (4) and 2008 (5) . The 2005 report showed that Australia’s canola growers were negatively impacted by the presence of state moratorium against genetically modified canola with potential losses of $3 billion in net present value terms in the period to 2015. This forecast is further supported by the 2008 ABARE report which showed the estimated economic benefit to Western Australia from adopting GM canola from 2008-09 for the following ten years would be $180 million in 2006-07 dollars. For New South Wales’ farmers (excluding those in the Murray Catchment Area) the benefit was estimated to be $273 million and South Australian farmers would receive a benefit of $115 million. Similarly, an academic study estimated that the GM canola moratoria in Australia cost farmers nearly $500 million in lost revenue (6). Such data is further supported by more recent independent market analysis by Mecardo (7) , in 2016 and 2017 which showed there is little evidence to determine that South Australia has achieved a premium for its non-GM canola crop due to the moratorium on GM technology. Comparing the difference between non-GM canola in Adelaide (SA) and Kwinana (WA) demonstrated a clear premium for non-GM canola in Kwinana throughout the entire season. There is even evidence of GM canola in Kwinana achieving a premium over Adelaide non-GM.
This data shows that state and territory based moratoria are negatively impacting Australian farmers and claims that perpetrate the need to maintain moratoria for marketing purposes are not valid.
Finding 20. Harnessing the economic and health benefits of gene technology: Benefit consideration
Corteva Agriscience proposes that the consideration of comparative benefits should not be excluded from regulatory decision-making but rather be scientifically based and used in consideration of innovation and technological developments. Such information may also assist public understanding and confidence in the Gene Technology Scheme.
Finding 21. Harnessing the economic and health benefits of gene technology: Regulatory burden
Corteva Agriscience agrees that regulation should always be commensurate with risk and not imposing undue regulatory burden which could stall the adoption of new technological advancements, both in Australia and globally.
Findings 22 and 23. Clarity on policy considerations of the Scheme
With respect to Finding 22, Corteva Agriscience supports the proposal that an opportunity exists for improved regulatory and policy clarity. Corteva Agriscience™ does not support the proposal of Finding 23 with respect to Schedule 21, specifically Schedule 21 (1) (aa) of the existing Scheme. As outlined in our response to Findings 18 and 19, we do not believe the claim for state or territory moratoria holds validity and rather suggest that the Review considers a repeal of Schedule 21 from the Scheme.
Findings 24, 25 and 26. Coordination with other regulators
Corteva Agriscience supports the proposal as per Finding 24, that a dedicated gene technology regulation web portal be developed.
We also concur that currently there is duplication of regulation as per Finding 25. Currently there is overlap between the OGTR, FSANZ and the Australian Pesticides and Veterinary Medicines Authority (APVMA) for products regulated as GMOs. To reduce this unnecessary duplication, time delays and costs, we recommend acceptance of risk assessments from the OGTR and FSANZ by APVMA or alternatively, remove the regulatory responsibility for GM products with incorporated pest and/or disease control by the APVMA.
With respect to Finding 26, Corteva Agriscience requests further clarity to be provided on such a proposal prior to providing comment.
Findings 27 and 28. Funding model
Corteva Agriscience agrees with Findings 27 and 28 with respect to full cost recovery and current funding levels.
4 Apted S., McDonald D., Rodgers H., 2005, Transgenic Crops: Welfare implications for Australia ABARE Australian Commodities, vol. 12, no. 3
5 Acworth, W., Yainshet., A, Curtotti, R, 2008 Economic impacts of GM crops in Australia ABARE Research Report 2008
6 Smyth, SJ (2017) Genetically Modified Crops, Regulatory Delays, and International Trade. Food and Energy Security 6:78-86.
7 Whitelaw A (2016) ‘Is the GM ban in South Australia providing a premium?’ Mercado Expert Market Analysis: 25 July 2016; and Whitelaw A (2017) ‘Controversial canola’. Mercado Expert Analysis: May 25 2017.
Findings - Theme 4 - Social and Ethical Issues
Findings 29 to 33:
Response
Findings 29 and 30. Public understanding and confidence in the Gene Technology Scheme
Corteva Agriscience agrees that the Scheme may be aided by additional communication mechanisms and that the Gene Technology Regulator and OGTR ought to continue to lead said activities.
Findings 31 and 32. Public understanding and confidence in the Gene Technology Scheme: Safety concerns and post market review
Corteva Agriscience believes that while currently there is public trust in the Scheme, some sections of the community have less trust with respect to GMOs. The science-based and unbiased education about GMOs is a continued necessity within the Australian society to strive for the entire community to be suitably educated and have trust in both the technology and the Scheme. Corteva Agriscience disagrees that further post-release review mechanisms are required to improve public confidence as the Scheme is designed to address all potential risks associated with environmental release. Public education outside the Scheme, as proposed by Finding 29, would be better suited to increase the level of trust within the Australian community.
Finding 33. Transparency and access to information for the Australian public
Corteva Agriscience agrees with the intent of Finding 33, in such, that a high level of transparency and access to relevant information will ensure trust and effective operation of the Scheme. As per Findings 29 and 30, we do support increased communications but would counsel the proponents of the Scheme to ensure that only relevant information that supports an increase in trust by the public.
Corteva Agriscience agrees that the Scheme may be aided by additional communication mechanisms and that the Gene Technology Regulator and OGTR ought to continue to lead said activities.
Findings 31 and 32. Public understanding and confidence in the Gene Technology Scheme: Safety concerns and post market review
Corteva Agriscience believes that while currently there is public trust in the Scheme, some sections of the community have less trust with respect to GMOs. The science-based and unbiased education about GMOs is a continued necessity within the Australian society to strive for the entire community to be suitably educated and have trust in both the technology and the Scheme. Corteva Agriscience disagrees that further post-release review mechanisms are required to improve public confidence as the Scheme is designed to address all potential risks associated with environmental release. Public education outside the Scheme, as proposed by Finding 29, would be better suited to increase the level of trust within the Australian community.
Finding 33. Transparency and access to information for the Australian public
Corteva Agriscience agrees with the intent of Finding 33, in such, that a high level of transparency and access to relevant information will ensure trust and effective operation of the Scheme. As per Findings 29 and 30, we do support increased communications but would counsel the proponents of the Scheme to ensure that only relevant information that supports an increase in trust by the public.