Review of National Gene Technology Scheme - Online Submissions

Synthetic biology
Gene drives
Gene Editing

In the first instance, I believe that one has to be cautious not to minimize possible risks by presenting the issue as one in which 'only small edits' of DNA are being made to an organism 'without introducing foreign DNA'. There is still a need to ensure that even 'small edits' are done with caution and based on substantial research that the benefits outweigh the risks. That said, potential impacts of edits to the DNA of an organism include both promised benefits but also risks including:
Benefits - New gene editing technologies are more specific and provide a more controlled and faster approach to introducing specific alterations of target-gene functions at precise locations in the genome (eg. for the purpose of gene silencing or enhancement of gene expression.) Gene editing in crops has been presented as having the potential to address food security issues (eg. by producing climate and pest resistant crops; increasing food production ability and speeds; being able to avoid viral infections.)
Risks- Genetically edited crops (like GM crops generally) do not provide perfect nor permanent solutions to the weed and pest pressure, new forms of resistance may/do develop, and the long-term consequences are unknown. Unintentional and currently unknown consequences may also arise, as is the risk again in GM crops generally. (I think this must however also be balanced against the knowledge that conventional breeding or mutation breeding, may also lead to unintended gene combinations or mutations.)
Perhaps the other thing that I would mention here, and in relation to all new technologies, is that there is also a need to consider the expense involved in onerous regulatory regimes and difficulties in gaining research funding. These other factors may skew what we see resulting from such technologies (be they big or small edits) in that research for the public good is very disadvantaged in comparison to the profit motive of large companies that can afford to do certain work and the associated regulatory costs. If research and appliciations are driven by profit rather than public good, then we need a strong regulatory system and checks and balances to ensure that public safety and benefit is protected, but at the same time, minimising expensive regulatory burdens where small DNA edits are found to be equivalent to conventional mutagenesis may be lead to lower development and approval costs, which could in turn lead to preventing/decreasing the small number of large private companies that may control the majority of GM crops and future outcomes.

I'm a bit confused by the question--are you saying that because you can't tell by looking at an organism whether new gene editing techniques have been used as opposed to conventional methods that it is too hard to regulate/enforce regulations?
If you know that the process involves gene editing then I believe that it is appropriate to regulate it under the GT Act. The onus should be on the researchers/producers to alert that they are using such techniques. Then you are able to monitor how such research and outcomes develop over time. I.e. The GT Act and regulatory scheme should also allow for consideration of research, what happens over time, and the end products. Tiered oversight and responses and flexibility would be desirable. I.e. overall, I believe that continued regulation and oversight should occur but that a flexible and responsive regulatory regime that is informed by research is necessary.

Again, I believe that following (and regulating) the research and emerging applications of new technologies is necessary. Again, I suggest that tiered oversight/regulation based on assessed risks and flexibility to enable responsive regulation informed by research is desirable and necessary.

Here I believe you are referring to gene drive technology being used to target invasive species. The potential implications of such release again have presented as having potential benefits but also risks.
As I understand the possible benefits (or theoretical hopes for gene drives) they may be able to address/prevent damage to the environment and negative impacts on agricultural output caused by incursions of pests (such as mammals, insects, weeds, birds, and fish). This could be done, for example, by altering inheritable genes to limit reproduction, and thus eradicating the pest; suppressing the ability of vectors to transmit disease to humans/livestock (eg. ticks, mosquitoes); introducing genes that make weeds and pests susceptible to pesticides; and/or reducing the need for chemical spraying and potentially increasing crop yields.
There are however risks. A lot has been said about the changes being able to spread uncontrollably without understanding of what the longer term consequences would be.
Possible ecological effects, intended or not, are far from clear. How long a gene drive will persist in the environment is unknown. There is also a lack of knowledge regarding whether a modified organism could pass the gene drive to an unintended recipient. How gene drives may affect the whole ecosystem is also an unknown, and our understanding of how genes move through populations and between species is not as advanced as it should be.
I am not supportive of an out and out moratorium, as I believe there is clearly a need for more laboratory research and confined field testing is needed to better understand the risks. But there needs to be recognition that at this stage of the science significant caution to prevent gene-drive modified organisms from being accidentally released into the wild should be taken. Other nations have recognised that there may also be concerns about gene drives from a biosecurity perspective both in relation to bio-terrorism (eg. via weaponsing gene drive), but also as a result of bio-error.
I suggest therefore that what is needed is greater transparency, and greater thought and action regarding not only the Australian regulatory scheme and how you will deal with gene drives but also how to coordinate and regulate such science internationally because really, such drives if released anywhere could be potentially being released everywhere. One must also note that the science is in relatively early stages of development, and there are still many questions yet to be answered about how, where, and why they may be developed and used.

I am supportive of the hybrid regulatory scheme that has been proposed - thus the triggers would be both process and product based dependent on a variety of factors. This would enable consideration and evaluation of risks regarding GM organisms being triggered by the process (as per the current regulatory approach), but also triggers in relation to the product (including such things as the product's novelty and risks of the individual trait/traits.)

It appears that the process approach is logically flawed in that while triggering a regulatory response because of the process used, it is fact not assessing the risk of the process itself, but is in fact concerned with the products that may result from the process used and the risks/benefits they may pose. Although I agree that we should be considering products that result from genetic modification - I believe logically we should be considering all such products and not just those that result from particular techniques as defined. I.e. the current approach of being triggered by process only could in effect mean that there could be a near-identical products that present equal risks/threats but because it is not a result of a process that triggers the regulatory system, it is not captured by the current regulatory scheme.

A hybrid system would enable capture of organisms that have been developed via a variety of techniques (some of which are evolving rapidly, some that are tried and tested) by considering not only a triggering process(es) but also products.

A hybrid scheme might also address the issue that that in some other cases, despite a process triggering the regulatory scheme the resulting product may pose little/no risk and thus a reduced regulatory burden may be called for.

Such a hybrid scheme may enable a more nuanced and flexible approach to regulation, assessment of risk, and regulatory responses/burdens than the current scheme.

Although I am supportive of a hybrid regulatory scheme, I believe when thinking through how to implement it, it will be important to determine which processes and products would and should trigger the scheme, and which would not.

Significant thought needs to be given to legislative definitions regarding what is or is not captured, and flexibility will again be necessary. It would be undesirable, for example, to necessarily subject all modified products, regardless of what process was used to make them, to the regulatory scheme as this might create an unnecessary regulatory burden. At the same time, perhaps a continuous loop of feedback from credible scientists, NGOs, community, and other contributors to determine the scope and bounds of what should fall within the regulatory scheme and to enable a more responsive regulatory system as research and understanding progress.

, because although this may ensure a rigorous regulatory review for all modified products, whether they were produced by mutagenesis, transgenesis, or new gene technology techniques, and remove the irrational result of similar products exhibiting the same trait but made by different technologies from being subjected to dramatically different regulatory requirements. It would also address concerns of some NGOs that companies would strategically utilize new modification technologies to evade regulatory requirements for transgenic products.

Ensuring public trust as well as scientific validity is essential.

In addition, how the system works with other current regulatory systems in Australia, regulatory approaches in other countries, as well as international law/regulation should be considered when shaping the hybrid system. This is important because the issues raised by rapid changes in technologies as they are applied to organisms and what is in turn produced are not confined within our own borders. In addition, such considerations may help shape the regulatory scheme to best protect against risks and negative impacts upon health, environment, and security, while also enabling positive benefits of new technologies to be explored and to progress.

As stated above I think a process only scheme is logically flawed. It captures some things that may not pose a significant risk, while not capturing products that may have almost identical modifications but are developed via non-triggering processes.
The scheme needs to be more nuanced, flexible, and responsive to allow research and development, while also being able to assess benefits and risks of a variety of processes and products.

I believe it is absolutely necessary to adjust the interface between the Scheme and other regulators to reduce redundancies but also to capture the fact that with advances in technologies come wider applicability across sectors. (Eg. agriculture; food; therapeutic goods; etc) It would be a positive step to create streamlined interfaces between regulatory schemes and to work together to ensure human health, environmental protection, and bio-security.

In relation to environmental release, it makes sense to again have a more nuanced regulatory approach. If something was assessed as 'low risk' based on rigorous research and evaluation, then it is logical to treat this differently to something that is assessed as high risk. A tiered regulatory system that is able to assess such risk and then have tiered responses and requirements would make more sense than treating all things the same even if they do not pose the same risks.

In relation to the DIY-biology movement, I believe it will be important to consider again that there are differences in what people are doing, and the products that result.

It needs to be recognised that DIYBio is interdisciplinary, there are biologists, engineers, software designers, artists, working side-by-side, and you see a variety of activity within this space ranging from building hardware to proof of principle work, genetics, synthetic biology, microbiology, zoology, and botany.

There are positives in the movement which has grown out of a desire to do something that is not necessarily driven or directed by grant funding (as happens in academic environments), or by commercial imperatives (as happens in high-cost biotech companies). It allows a space for experimentation, practice, creativity, without a financial imperative.

Predominantly, DIY Bio is a community-based activity in that most people work with others. One study found that 92% of people work in group spaces, and around only 8% of people work exclusively at home. Many such people also work in multiple spaces – work in academia/government; a hackerspace; community labs; and home. (Noting that contrary to the belief that 'hacking' involves some kind of criminal activity, you find a culture that can be defined by four interrelated goals - (i) to investigate a subject for its own sake, (ii) to engage in non-destructive mischief, (iii) to do something out of the ordinary or clandestine and (iv) to crack the inaccessible.

As such it DIY bio can be a form of self-driven practice, experimentation and problem-solving, which encourages people to move out of the establishment and to do biology, to experiment, and to create. In this sense, I do believe that while some aspects of the DIY-biology movement may be captured by the scheme, it is important that the scheme does not stifle the opportunity for people to engage in science at all levels (i.e. not to be crushed by expensive regulatory requirements).

There needs to be a balance and particular consideration to ensure that regulation is not based upon uninformed fear in relation to ‘dangers’ associated with DIYBio that amateurs will create new viruses or pandemics. I note that in one survey it was found that the majority of DIYers have extracted DNA – eg. from a strawberry. Around 50% of people report having genetically engineered bacteria or a yeast. (This is really one of the first genetic engineering experiments a high-school or college student would do in a lab at school), and around 20% have synthesized a gene.

Perhaps most feared is that DIYBio is open to anyone and that there might be some rogues, or where the science may go and there are both promises and perils in that. But really the same can be said in relation to all science. That is not however to dismiss all risks.

I believe therefore that there might be some separate regulation required for the DIY-biology movement dependent on what exactly one wants to do. The OGTR has a role in that it is tasked with identifying and managing risks to human health, safety and the environment arising from dealings with genetically modified organisms (GMOs); the restriction of certain forms of dealings with GMOS unless such dealings are exempt or otherwise authorised; and criminal offences for non-compliance. In addition there are national standards which act as "guidelines" for construction and operation of various lab facilities such as AS/NZS 2243.3; and other regulatory agencies and laws too, that may or may not apply in relatiton to DIY-Bio. For example:
• Food Standards Australia New Zealand (FSANZ), is responsible for examining the safety of GM foods (Food Standards Code);
• The Australian Pesticides and Veterinary Medicines Authority (APVMA), operates the national system that evaluates, registers and regulates all agricultural chemicals (including those that are, or are used on GM crops) and veterinary therapeutic products under the Agricultural and Veterinary Chemicals Code Act 1994 and the Agricultural and Veterinary Chemicals Administration Act 1994;
• The National Industrial Chemicals Notification and Assessment Scheme (NICNAS), provides a national notification and assessment scheme to protect the health of the public, workers and the environment from the harmful effects of industrial chemicals under the Industrial Chemicals (Notification and Assessment) Act 1989;
• The Therapeutic Goods Administration (TGA), administers the Therapeutic Goods Act 1989 that provides a national framework for the regulation of medicines, medical devices, blood and tissues in Australia, including GM and GM-derived therapeutic products, and ensures their quality, safety and efficacy; and
• The Australian Quarantine and Inspection Service (AQIS), regulates the importation into Australia of all animal, plant and biological products that may pose a quarantine pest and/or disease risk. Import permit applications must indicate the presence of a GMO and the Office of the Gene Technology Regulator authorisation.

With this in mind, perhaps the scheme can accommodate the DIY-Bio movement better by again considering a tiered system . I.e. a basic registration if one is opening a simple community lab to increased regulation (eg. a licence and greater oversight) if a lab engages with matters that may create more risk (eg. those captured by the GM regulatory scheme otherwise). (This balances calls such as those of Harvard synthetic biologist George Church who has proposed the precautionary measure of requiring licenses for DIY synthetic biologists is necessary, with recognition that people argue that over-regulation will just drive people underground.) It should be noted that there are also what is referred to as ‘soft regulatory’ options too in that there are Codes of conduct and ethical undertakings being established by DIYers, as a means to self-regulate.

Overall, I believe there is a lot of regulation that really needs to be streamlined and made more clear. Legislation and regulatory regimes are often playing ‘catch up’ and regulatorys state they are ‘keeping a watchful eye’, but perhaps there is also an element of not really knowing what DIY-Bio is, or where it is going. Again, I therefore strongly advocate flexible regulatory systems that can respond when needed, but that doesn't unnecessarily say ‘No’ to everything… If there are to be changes in regulation, I believe it really important that policymakers engage with DIYers to shape a more comprehensive policy that delineates what DIYers can self-regulate, and when the government should intervene.

The scheme needs to require more transparency in science and industry as well as accountability, participation (eg. engagement with the public and regulated communities) as well as capacity building in relation to understanding and adhering to the scheme. These things together would support how the scheme is viewed and operates.

I believe that rapidly changing technologies require far more flexible and responsive regulatory and governance approaches that the stock standard legislation that can be extremely slow to change or becomes outdated and does not actually capture what it was intended to capture.
Ongoing consultation, advisory committees, and the power to issue directives/conditions that are responsive to changes in knowledge and risk assessment, and that have force, is required.

See above. I believe that with the rapidity with which regulated technologies change there needs to be ongoing evaluation and responsiveness, and not only a major review every five years -- which by the time it is completed means the law may lag years behind the changes/innovations/research evidence/etc.

See above.

I have addressed my views on moratoria above. I do not support complete moratoria, but rather careful and cautious research so that we can actually understand benefits and risks.

There needs to be better transparency, accessibility, explanation, and communication with the public about areas of complex science-based technology. Research evidence should be communicated in a direct way, and fears addressed.

My perception is that the Australian community likes to see things regulated if they perceive a risk. I think it would be best to maintain regulation, but to ensure that community confidence in such regulation is not misguided. Making the scheme more streamlined, flexible, responsive, and able to adjust to advances in science, understanding, benefits, and risks, and to communicate this, would enhance confidence in the scheme.

See my response above.

The public needs to know that science is being practiced in a transparent and accountable way. That industry and commercial interests are not placed above human health, environment, and safety. Advances, and assessments of benefits and risks, need to be clearly communicated.

If the government has a regulatory body then perhaps that body is best placed to provide information.