Response 95816771

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Theme 1 - Technical Issues

What technological advances can be foreseen that might pose regulatory challenges for the Scheme?

Response
All of those which will not be regulated. We are dealing with a very new technique and much remains speculation or are unknown.

What are the potential impacts of the capability to make small edits in the DNA of an organism using no foreign DNA?

Response
As yet we do not know, but off -target changes are possible and therefore these techniques (such as CRISPR) need to be regulated.

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
Patent control will make them identifiable and therefore they will need to be labelled.

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?
All carry risks and should be regulated.

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 should not be allowed. Recent theories on gene drives suggest off target or out of field site is possible and uncontrollable. Therefore a total moratorium should be put in place regarding gene drives.
What are the technical issues to consider in the scenario of a GMO used to target an introduced plant, vertebrate or invertebrate pest?
They are too risky and should be banned.

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
All techniques using genetic engineering/gene editing should be the trigger.

What factors need to be taken into account in the design of a product-based or a hybrid process/product regulatory scheme?

Response
Regulations should begin with the process trigger.

Phase one consultations identified a number of functional efficiencies that could be applied to the Scheme. The Review is exploring these issues from perspective of the existing process-based regulatory scheme:

Are there any ‘fixes’ the scheme needs right now to remain effective?
Yes, too much reliance is placed on Industry generated data to show safety of GMOs at the moment. This is unreliable and unsatisfactory. More independent studies should be used.
How would you streamline the existing scheme?
The main policy of ensuring the health and safety of people and environment should be put before industry profits. The system appears to be already streamlined to approve all submissions, despite the rejection of several events by other jurisdictions. More independence should be apparent.
What efficiencies could be gained through adjusting the interface between the Scheme and other regulators?
Make the OGTR the lead regulator to prevent the problem of 'passing the buck'.

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?
There is no value in a tiered system. Each event has the potential for success and failure and each should be dealt with accordingly, with care and consistent regulations.
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?
Where is the value in 'fast -tracking' when such new techniques are all capable of off-target consequences.
Under a regulatory framework to tier risk for environmental release, what efficiencies might be delivered to regulated stakeholders?
While Industry may value deregulation and fast tracking it will not gain public confidence and support.
How could efficiency gains to the Regulator be quantified?
Deregulation will come at a cost to the public and the 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?
There is none. This is just one of the problems with GM crops and why the public are unaccepting of them. They should be dealt with as medical GMOs and be thoroughly tested including long-term, generational feeding trials.
In what way might different applications be treated differently (e.g. medical, agricultural, industrial, environmental, etc)?
Each event should be dealt with individually but each should be thoroughly tested.
How might the Scheme accommodate the DIY-biology movement?
It is ridiculous that people are able to buy 'bio-hacking' kits on the internet. This should be stopped until clear regulations are put in place as to what should be available and to whom, and in what type of controlled space. Trivialising these new techniques ignores the potential for error and unexpected and potentially dangerous outcomes.
What measures might be warranted to identify potential long-term or ‘down-stream’ effects of gene technologies on humans and the environment?
Currently we have unlabelled GM-derived food in our shops, being fed to Australian families and we are all guinea pigs with nobody studying the consequences because the producers of these events have told our regulatory bodies that their GMOs are safe. It is time that we had independent science looking at this.
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?
States should retain the right to approve GMOs based on economic value.
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 lack of transparency in GM food does not create public support for GMOs. Protection for non-GM growing farmers also needs to be put into place.

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?
I believe that New Zealand will be regulating the new gene editing events. I would have to ask how trade between Australia and NZ would continue if events from gene editing were to be exported to NZ. Lack of transparency and harmonisation does not enhance trade prospects.

Theme 3 - Governance Issues

What will reassure the Australian public and regulated communities of the integrity of the Scheme?

Response
People do not trust our regulatory to look after our best welfare when to comes to GMOs. We mistrust the refusal to adopt transparent GM labelling which the EU has enjoyed for the last two decades.
The reluctance to accept independent science which raises concerns regarding the safety of GMOs is also disturbing for the public.
The push to deregulate these new gene editing events again makes the public concerned that Industry needs are put before the health and safety of people and the environment.

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
There is a real lack of transparency with regulatory bodies and their lack of accessibility to the public.

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?
First and foremost the health and safety of people and the environment.
Transparency and public access to decision and changes.
What criteria should be used to determine what legislative amendments are minor and could be progressed without going to the Forum?
There should be more transparency about what is being proposed.

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?
GM-free states have unfettered access to all markets while GM growing states have non-GM farmers carrying the burden of maintaining segregation. in order to continue trading to non-GM demanding markets.
How could regulated stakeholders access the benefits of a national scheme, whilst ensuring jurisdictions are able to effectively trade in the international context?
GMOs have been introduced into Australia heavily relying on them being invisible. We have no knowledge of who is growing GM crops, where it goes after harvest and where it ends up in our food. The majority of consumers would avoid GMOs given the choice. This is not a even playing field . Trade is not effective nationally . Let us get that right first and allow consumers the right to choose to be part of this experiment.
What other mechanisms could be utilised in order to realise the outcomes currently achieved through moratoria?
GM labelling, stricter controls on GM growers in order to rebalance the responsibility in maintaining segregation between GM and non-GM crops.

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?
With the majority of consumers opposed to GMO s it is hard to see what benefits have been achieved. We are always being told what GMOs will achieve while the reality is the arrival of two crop types, each engineered to end up with elevated levels of pesticides inside them, which are then fed to farm animals or put into processed food s for us. All unlabelled and invisible.
New techniques will be the same. We will be in the dark, being used as guinea pigs with nobody doing the research to see what effect this experiment is having on us.
Should other policy principles be developed that are tailored to horizon technology management?
WE must keep coming back to the main policy...the health and safety of people and the environment.

Independent science must be considered alongside data from Industry.

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?
To continue to regulate all new GM events including gene editing techniques.
What other mechanisms would provide suitable policy clarity that would enhance the Scheme and support compliance?
Regulate and label all events.

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?
Confusion over what a GMO is. The inconsistency on what product is GM and what is non-GM and why the emphasis and responsibility is so strict on non-GM labelling when there are virtually no rules on GM labelling.
How can existing coordination functions be utilised more effectively to support the Scheme to be agile and facilitate transitions across regulatory framework boundaries?
The OGTR must be the lead regulator.

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
Transparency and GM labelling which enhance consumer confidence.

Where does the community have confidence in the gene technology regulatory scheme? How can this be maintained?

Response
I am not aware of any confidence in the regulatory system mostly due to the lack of transparency and GM labelling. The potential to deregulate gene editing events will enhance the mistrust.

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
The public needs to know that approvals of GMOs are not solely based on industry data, not accessible to the public, and where independent research showing concerns is rejected.

What does the public need to know?

Response
Transparent GM labelling and regulations on any new GM technique must be put into place.

Who is best placed to provide that information?

Response
Food producers should label all GM-derived foods. This is the best way to educate the public.

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?
Transparency and GM labelling.
Encouraging choice, and not just ensuring that the public is eating in the dark.
What does the public need in order to determine whether to provide social licence for the adoption and embedding of gene technology into the culture, lifestyle, economy and health sector?
Is this about marketing? The reason the public is so reticent to engage with GMOs is because they have been denied access to transparency and choice for so long.
We have heard about all of the new techniques which will come in the future, but meanwhile we are invisibly and unwittingly eating food which we do not trust due to it being allowed to avoid the labelling standards which the EU has had in place for the last 20 years.
What are the ethical considerations for enabling access to medical treatments?
Informed consent would be a start.

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?
I believe the GM Industry itself is doing its own advertising at the moment. I fail to see why regulatory bodies or governments should push the benefits of these techniques while allowing them to be protected by a shroud of invisibility since their introduction.
Is the Scheme putting up barriers to research and development and commercialisation of agricultural applications?
As far as I can see the only impediment is the refusal of the R&D team to acknowledge the changing requirements of the public. There is a global movement away from food based on price, and instead food based on health is being demanded. This is due to health concerns, specifically the rise in allergies and gut problems. GMOs do not fit into this idea of 'healthy' foods.