Introduction
Are you providing a submission as a representative of an organisation?
If yes, what is the name of your organisation?
Council of Rural Research and Development Corporations
Findings - Theme 1 - Technical Issues
Findings 3 to 7:
Response
In relation to Finding 3, the Council notes that work to examine definitions should be conducted in a timely manner, taking into account any concurrent work, and to provide regulatory certainty particularly for the research community.
The Council makes the following comment in relation to Finding 6:
-The Council is not in favour of a system which would require dual consent/approval by multiple regulatory authorities.
-Any additional requirements should not be onerous or prohibitive as barriers to technology adoption will stifle innovation.
-It is preferred that post-release detection and monitoring requirements only be applied during field trials - i.e. not post commercial release.
-It is critical that additional non-scientific regulatory burden and instruments outside the remit of the Regulator's current tools, are not implemented. Risks from GMOs can be assessed within the current scheme.
The Council makes the following comment in relation to Finding 6:
-The Council is not in favour of a system which would require dual consent/approval by multiple regulatory authorities.
-Any additional requirements should not be onerous or prohibitive as barriers to technology adoption will stifle innovation.
-It is preferred that post-release detection and monitoring requirements only be applied during field trials - i.e. not post commercial release.
-It is critical that additional non-scientific regulatory burden and instruments outside the remit of the Regulator's current tools, are not implemented. Risks from GMOs can be assessed within the current scheme.
Findings - Theme 2 - Regulatory Issues
Findings 8 - 15:
Response
The Council supports most of these findings but notes the following comments:
Finding 8: Should the process trigger continue, the regulation imposed must be aligned with the level of risk. This may require changes to some of the existing definitions. The continuation of the process trigger is supported providing that the approach does not impose regulation that is disproportionate to the level of risk. Australia must retain a science-based system and case-by-case approach.
Finding 12: This could be supported by enhanced communication efforts to ensure there is greater awareness of Australia's gene technology regulatory scheme. In addition, it should be noted that over regulation and onerous monitoring and reporting requirements targeting smaller enterprises has the potential to stifle innovation and limit technology options available to industry.
Finding 13: Recommendations that allow for new technology developments to be considered on a case-by-case basis, based on elements of principled-based regulation are welcomed. It is critical that regulation is not disproportionate to the level of risk for newer technology.
Finding 15: The Council supports the GTR/OGTR engaging with countries to ensure market access and international trade AND also to engage in outreach and capacity building with those nations developing gene technology regulatory schemes to ensure science-based, consistent global frameworks.
Finding 8: Should the process trigger continue, the regulation imposed must be aligned with the level of risk. This may require changes to some of the existing definitions. The continuation of the process trigger is supported providing that the approach does not impose regulation that is disproportionate to the level of risk. Australia must retain a science-based system and case-by-case approach.
Finding 12: This could be supported by enhanced communication efforts to ensure there is greater awareness of Australia's gene technology regulatory scheme. In addition, it should be noted that over regulation and onerous monitoring and reporting requirements targeting smaller enterprises has the potential to stifle innovation and limit technology options available to industry.
Finding 13: Recommendations that allow for new technology developments to be considered on a case-by-case basis, based on elements of principled-based regulation are welcomed. It is critical that regulation is not disproportionate to the level of risk for newer technology.
Finding 15: The Council supports the GTR/OGTR engaging with countries to ensure market access and international trade AND also to engage in outreach and capacity building with those nations developing gene technology regulatory schemes to ensure science-based, consistent global frameworks.
Findings - Theme 3 - Governance Issues
Findings 16 - 28:
Response
The Council makes the following comments:
Finding 18: The moratoria legislation has allowed for political decision making rather than science-based decision making and in doing so, has broken down a world class regulatory scheme. In addition, the moratoria have, in some instances, limited the choice of R&D partners and Australia's ability to leverage R&D technology and tools.
Finding 22: It is critical that the Gene Technology Regulator retains the power to make technical, scientific determinations regarding the scope of the regulatory oversight needed, as has been done under the Technical Review. Such an approach ensures that decisions are science-based and independent of the political process. If more work is taken on by "the Forum" this could result in more politically-based decisions. Should "the Forum" commence such work, it must retain a focus grounded in science and include engagement with relevant stakeholders.
Finding 23: Such an approach would require further consultation, as the current Policy Principle on designated areas has proven to be problematic/non-science based.
Finding 24: The Council supports greater communication and engagement.
Finding 18: The moratoria legislation has allowed for political decision making rather than science-based decision making and in doing so, has broken down a world class regulatory scheme. In addition, the moratoria have, in some instances, limited the choice of R&D partners and Australia's ability to leverage R&D technology and tools.
Finding 22: It is critical that the Gene Technology Regulator retains the power to make technical, scientific determinations regarding the scope of the regulatory oversight needed, as has been done under the Technical Review. Such an approach ensures that decisions are science-based and independent of the political process. If more work is taken on by "the Forum" this could result in more politically-based decisions. Should "the Forum" commence such work, it must retain a focus grounded in science and include engagement with relevant stakeholders.
Finding 23: Such an approach would require further consultation, as the current Policy Principle on designated areas has proven to be problematic/non-science based.
Finding 24: The Council supports greater communication and engagement.
Findings - Theme 4 - Social and Ethical Issues
Findings 29 to 33:
Response
The Council makes the following comments:
Finding 29: Consideration should be given for the OGTR to have a dedicated communication resource rather than relying on an ‘external’ agency.
Findings 30 and 31: The Council encourages greater communication to build awareness and understanding.
Finding 32: Once a ‘product’ has been approved for release, communication about the release and the product largely becomes the responsibility of the commercialising entity and the relevant industry. Further surveillance, post-release, by the GTR should not be required as the product has been deemed safe for human health and the environment. In the long history of commercially cultivated GM crops worldwide, it would be hard to find a justified basis for what is proposed in this finding.
Finding 33: The Council supports ongoing and enhanced communication.
Finding 29: Consideration should be given for the OGTR to have a dedicated communication resource rather than relying on an ‘external’ agency.
Findings 30 and 31: The Council encourages greater communication to build awareness and understanding.
Finding 32: Once a ‘product’ has been approved for release, communication about the release and the product largely becomes the responsibility of the commercialising entity and the relevant industry. Further surveillance, post-release, by the GTR should not be required as the product has been deemed safe for human health and the environment. In the long history of commercially cultivated GM crops worldwide, it would be hard to find a justified basis for what is proposed in this finding.
Finding 33: The Council supports ongoing and enhanced communication.