What technological advances can be foreseen that might pose regulatory challenges for the Scheme?
Response
Advances in the field of gene technology have been experienced globally since the 1990s. It is an ever-changing field and somewhat expected that this situation may occur. To safeguard the environment and human health it is imperative that full transparency and communication from industry should occur. Before research and development commences in the field, the question should be asked, is gene technology where the solution lies for this particular problem? For example, in the agriculture industry, genetically modified (gm) plants have had increased yet limited yields with a high reliance on fertiliser, pesticide, herbicide and water and controlled by a oligopoly. Sustainable practices need to be developed first.
In relation to regulatory challenges, by its very name, any technology, advancements, horizon techniques regarding gene technology should be recognised under the broad definition and concept within the Gene Technology Act (the Act) and therefore be regulated.
What are the potential impacts of the capability to make small edits in the DNA of an organism using no foreign DNA?
Response
The potential impacts of companies being able to make small edits without legislative boundaries, regulation, compliance, auditing, reporting, tracking and recording is that successions of small edits upon small edits result in a holistic significant edit which is far removed from the original definition of an small edit in the Act. Additionally, it is not a transparent process or transparent end product.
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
Gene editing should be regulated under the Act. If it is difficult to differentiate between a gene edited modified organism product and products with an identical genome, then the review of enforced kept records, process regulation, compliance checks, scientific history documentation states what has happened to that product and where it came from.
Given the potential short and long-term damage genetically modified organisms could have on food, agriculture, the environment, health, economy, it is my view that it would be entirely practical, efficient and appropriate to regulate this industry.
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?
Legislation and compliance regulation representatives should be required to be stakeholders in gene technology research and development. Horizon changes and advancements are therefore known, understood and representatives are familiar with the terms and definitions. If terminology changes or differs too much from the broad definitions in the Act, then additional work will be required to update the legislation and supporting instruments. The impacts of gene technology are widespread over may fields and aligned government agencies (for example environment, health, primary industry) with each specialty area requiring stakeholders. Information could be captured through reporting and compliance audits.
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?
This is very dangerous ground and the impacts are extremely far-reaching. Releasing a GMO into the environment is such a high risk. The actual impact is a large unknown. Modelling can be performed indeed however the actual impact may be significantly different.
I intensely oppose GM animal breeding technology such as cloning, gene transfer and sex control and others. It is my view that these technologies are morally repugnant.
What are the technical issues to consider in the scenario of a GMO used to target an introduced plant, vertebrate or invertebrate pest?
In a clinical space, the morphology etc may be predicted however, when an organism is in an environment and is unconstrained, it may develop characteristics that cannot be controlled that may or may not have been identified and risk assessed.
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
Process and product
What factors need to be taken into account in the design of a product-based or a hybrid process/product regulatory scheme?
Response
A hybrid scheme would be more appropriate.
Broad definitions to encompass technological change and emerging technologies with examples of scenarios.
The Review is exploring whether greater alignment of regulation with risk should be further developed for environmental releases:
What support exists for a regulatory framework providing for tiered risk?
Environmental release is always going to be a high risk scenario for GMO as the behaviour of the GMO is largely unknown in the physical and natural environment.
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?
All are living beings and as animals are sentient beings they have the highest risk.
I vehemently oppose the use of GMO/gene editing/gene technology on animals. The impacts on plants and microbes are also related to the natural predators/users of those plants and microbes.
In what way might different applications be treated differently (e.g. medical, agricultural, industrial, environmental, etc)?
All fields have a relationship and impact on each other.
How might the Scheme accommodate the DIY-biology movement?
How does DIY-biology even become a thing? It does not sound safe.
What measures might be warranted to identify potential long-term or ‘down-stream’ effects of gene technologies on humans and the environment?
Look to history and what other countries have done/are doing.
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?
Principles such as?
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?
Ethics and morals. Just because it can be done does not mean it should.
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?
What is unclear is the public's view regarding GMO. Not the people responding to this submission - the mass public? Are consumers willing to buy GMO products or will consumers just be kept in the dark because branding is a separate issue? Is there a market and for what?
Theme 3 - Governance Issues
What will reassure the Australian public and regulated communities of the integrity of the Scheme?
Response
Wide communication of the scheme.
Wide communication of which products/companies incorporate gene technology so consumers are aware and can make up their own mind if they want to use it.
No conflict of interest between politicians/politics and government agencies.
No secret agendas.
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
The Scheme and Regulator cannot be politicized.
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?
All interacting stakeholders need to be involved to discuss the GMO concept, risk assessment, requirement of the GMO, better ways of living, community outreach group ambassadors.
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?
For once, can humans not be driven by jobs and growth and money and profit?
Can we not look after this planet, learn from the past mistakes, be innovative and sustainable? The question must be asked - where agriculture/primary industry is regarded, the world's starving can be fed, carbon emissions and methane can be decreased through the reduction of meat in the diet and the protection of forests as carbon sinks not wide scale deforestation to turn forests into carbon sources for cattle grazing.
Theme 4 - Social and Ethical Issues
How do we help the community to best understand the benefits and risks of a complex, science-based technology?
Response
Ensure it is science-based. Communicate the why, the how, the benefits, the risks and the negatives so people have full information.
Where does the community have confidence in the gene technology regulatory scheme? How can this be maintained?
Response
I do not have confidence in gene tech. I research products and only buy brands that do not contain GMO. I do not want to eat frankenfoods.
Where is there a lack of community confidence in the gene technology regulatory scheme? Why might this be, and how can confidence be built?
Response
Most people do not even know it exists or even know that they are eating GMO.
What does the public need to know?
Response
What is GMO in plain language
Why there is GMO - evidence and fact based
Which brands/companies
Benefits to environment/people etc
Costs to environment/people, etc.
Who is best placed to provide that information?
Response
Not a figure with a conflict of interest Redacted text
The Review is seeking to better understand how to balance consumer choice within the scope of the Scheme:
What does the public need in order to accept the increasing availability and range of use of gene technologies?
Why should the public accept gene tech? Why can't the public reject it as too high a risk?
The Review is seeking to explore and better understand factors relating to choice and the potential impacts on trade, alternate farming techniques and the broader environment:
How do we ensure that information is available to the community on the value of GM and what it can do? Who is responsible for providing this, and why?
This survey is clearly gauged toward the weakening of legislation to make it easier for gene tech to move forward with its agenda and keeping consumers in the dark. Publicise the facts in an unbiased and easily accessible way.