Theme 1 - Technical Issues
What technological advances can be foreseen that might pose regulatory challenges for the Scheme?
Response
CrispR/Cas
What are the potential impacts of the capability to make small edits in the DNA of an organism using no foreign DNA?
Response
Such modified organisms would fall outside the current definition of a GMO.
Under what circumstances might it be practical, efficient or appropriate to regulate gene editing under the GT Act when, from an enforcement perspective, it may not be possible to distinguish the products of gene editing from the products of conventional methods?
Response
The point is whether the modified phenotype should be regulated (which I believe it should not - I prefer option 4), or the technique. In the timeframe of the current review I do not believe it is practical to enforce monitoring of the genotype. If the process is regulated then the modified phenotype should be monitored and declaration of the use of the process the responsibility of the IBC.
The emerging applications, and their definitional implications for research purposes, are another area the Review will consider:
Do these applications of gene technologies present unique issues for consideration? If so, how might these issues be best addressed by the Scheme?
no comment.
The Review is seeking further input on the prospect of the intentional release of a GMO or organism with changed characteristics, delivered by one of the new breeding technologies, into the environment:
What are the potential implications of the release of a GMO targeting an invasive species in Australia?
In my opinion this is a broad question. It is a case by case issue. The potential implications could be neutral, negative or positive, depending on the altered phenotpye and genotype.
What are the technical issues to consider in the scenario of a GMO used to target an introduced plant, vertebrate or invertebrate pest?
It is a case by case issue. The potential implications could be neutral, negative or positive, depending on the altered phenotpye and genotype and the target organism.
Theme 2 - Regulatory Issues
What do you think is the most appropriate regulatory trigger for Australia in light of extensions and advancements in gene technologies?
Response
Introduction of foreign DNA.
What factors need to be taken into account in the design of a product-based or a hybrid process/product regulatory scheme?
Response
No comment.
The Review is exploring whether greater alignment of regulation with risk should be further developed for environmental releases:
What examples exist of licence applications to the Regulator that could be ‘fast-tracked’, under a risk tiering system, with evidence of scientific and technical integrity that the aims of the Scheme (protection of human health and the environment) will be delivered?
Cut flowers - introduction of the same phenotype into a different background variety.
Cotton - introduction of the same phenotype into other varieties through breeding.
Cotton - introduction of the same phenotype into other varieties through breeding.
Under a regulatory framework to tier risk for environmental release, what efficiencies might be delivered to regulated stakeholders?
No fees.
How could efficiency gains to the Regulator be quantified?
Less review time by staff.
The Review is exploring whether a distinction can be made between classes of organisms so the necessary controls can be applied to the highest risks, rather than applying a one size fits all approach:
What justification is there to regulate animals, plants or microbes differently?
Plants can b regulated differently as they have slower modes of spread if they are sterile or male sterile, or only spread vegetatively, or are only found in produced in contained facilities.
In what way might different applications be treated differently (e.g. medical, agricultural, industrial, environmental, etc)?
Where the modified organism is used as a source of extracted chemicals and the novel chemical is the final target product.
How might the Scheme accommodate the DIY-biology movement?
DIY Biology should be subject to the same regulations as any other organisation and should have an IBC or access to an IBC.
What measures might be warranted to identify potential long-term or ‘down-stream’ effects of gene technologies on humans and the environment?
No comment.
What opportunities are there for principles-based regulation in the Gene Technology Scheme? What advantages could be gained from doing this? What drawbacks are there from such an approach to regulation?
No comment.
Are there any non-science aspects that would enhance the object of regulation, that do not place unnecessary burdens on the regulated community? How might these be considered?
The regulation should be primarily based on science. I believe the current committee structure within OGTR is adequate.
The Review is exploring the practical implications to the Scheme of harmonising Australian regulation with the regulatory needs of trade partners:
What are the potential impacts on market access for exporters of animal or plant derived food products?
Te international trade is already non-harmonized. Whatever regulation Australia decides will not be consistent with those finally adopted in the EU, Japan , US, China. As has been the case for the last 20 years, developers will need to work within multiple different regulatory frameworks.
Theme 3 - Governance Issues
What will reassure the Australian public and regulated communities of the integrity of the Scheme?
Response
No comment.
What mechanisms could address the challenges that making changes in the Scheme might entail: Domestically – across a federated government system experiencing different political agendas and community sentiments? Internationally – relating to other agreements, trade agreements, and harmonised regulatory approaches?
Response
No comment.
The Review is exploring how to ensure the rate of adaptation of the Scheme keeps pace with changes in technology and community values:
What principles should guide the level at which a decision is made within the Scheme?
No comment.
Does reviewing the Scheme every five years best address the needs of the Scheme? Is there a preferable option?
I am comfortable with a five year cycle.
Is the existing role of the Forum the most suitable way of providing oversight and guidance for the Scheme?
No comment.
What criteria should be used to determine what legislative amendments are minor and could be progressed without going to the Forum?
No comment.
GM moratoria remain a debated element of the Scheme and the Review is seeking to understand the factors and practical implications for all stakeholders:
What evidence is there to support economic and trade advantages of GM moratoria – or indeed, the absence of GM moratoria?
There is no evidence I am aware of either way.
How could regulated stakeholders access the benefits of a national scheme, whilst ensuring jurisdictions are able to effectively trade in the international context?
No comment.
What other mechanisms could be utilised in order to realise the outcomes currently achieved through moratoria?
The outcomes of moratorium are simply to stop use of a developed technology, used in other parts of Australia or overseas. This is the realized outcome and legislative "bans" is the only way to get to the same outcome.
The Review is exploring how the Scheme can harness the emerging benefits of gene technology, that were not anticipated at the establishment of the Scheme:
Are existing mechanisms, when used effectively, sufficient to ensure the emerging health, environmental and manufacturing benefits of gene technology that were not anticipated at the establishment of the Scheme, can be harnessed for Australians?
No comment.
Should other policy principles be developed that are tailored to horizon technology management?
No comment.
What other factors could be considered in the regulatory decision?
No comment.
What data sets are required to assist the regulator to consider benefits in addition to the risks?
This, again, is a case by case situation.
The Review seeks to identify areas where clear policy positions could enhance the Scheme and support compliance with regulation:
What aspects of gene technology would benefit from greater policy position clarity?
CrispR/Cas
What other mechanisms would provide suitable policy clarity that would enhance the Scheme and support compliance?
No comment.
The Review is seeking to identify any regulation gaps and overlaps at the interface of the Scheme and other product regulators:
What are the pressure points at the boundaries between regulatory schemes that are caused by regulatory gaps or overlaps?
No comment.
How can existing coordination functions be utilised more effectively to support the Scheme to be agile and facilitate transitions across regulatory framework boundaries?
It would be nice if DAWR had the capacity to approve their own facilities as PC2, PC3 etc when they meet the OGTR standards.
What other activities would enhance this?
No comment.
What amendments to the funding model would support an agile Scheme that will cope with increased future activity?
There should be no application fees and no annual license fees..
How could some aspects of the Scheme be funded through other mechanisms that will support innovation and competition in gene technology, whilst retaining public confidence in the Scheme?
Application fees would serve as a deterrence to development of the technology.
If fees are to be imposed on developers via the scheme, these should b tax deductible.
If fees are to be imposed on developers via the scheme, these should b tax deductible.