Submitter / Submission
Francesca Agosti / The Government is proposing changes to our Gene Technology Regulations which would make Australia the first country in the world to deregulate a range of new genetic modification (GM) techniques in animals, plants and microbes.
If the Office of the Gene Technology Regulator (OGTR) deregulates these new GM techniques there will be no monitoring or surveillance. Anyone from amateur biohackers, to industry, to terror groups would be free to use them to genetically modify plants, animals and microbes. Entirely new diseases and poisons could be made. And they could enter our food chain and our environment with no safety testing and no labelling. The risks are enormous and the results could be catastrophic.
I STRONGLY opposed the watering down of these Regulations.
Reviews commissioned by the Austrian and Norwegian governments concluded that not enough is known about the risks posed by these new GM techniques. They recommended that products derived from them require comprehensive case-by-case risk assessments.
I ask you to oppose any changes to the current Gene Technology Regulations.
Shannon AhGee / I am opposed to Australia, my family and my future grandchildren being treated as test subjects for GM science.
We already have a world proven, reliable, effective, ethical, nutritious, and deeply gratifying design system for producing the best quality, most nutritious, ethical, peaceful and respectful food for ourselves – permaculture.
A greater understanding of our relationships & connections within our environment, rather than controllers and manipulators of it – is what is going to win hearts and minds and keep workforces strong and vibrant. Anything else suggests interests in controlling and manipulating a population also. Against. Firmly. What becomes of your grandchildren?
Carlos Andrade / I would like to express my deep disquiet at the proposed deregulation of new genetic-modification techniques in Australia. I would also like to express my deep disquiet over the fact that our regulators of GM technology in Australia base their ‘regulations’ simply on what the GM industry desires them to do!
New genetic-modification techniques such as CRISPR, ODM, SDNs, ZFN carry with them risks that are currently unable to be defined, as government agencies in Norway and Austria have already concluded. Due to the fact that these risks are unclear, the potential for disaster is immense! There should be a comprehensive case-by-case assessment of any proposed use of these techniques, with independent safety testing in regard to human health and the environment. All products created from these techniques should be clearly labelled to maintain the choice of farmers, consumers etc.The government should demand strict liability for licensees and owners of GM patents when it comes to the use of these new GM techniques -and any resulting losses and costs derived from their use. However, I think that there should be a ban on all commercial use of these new GM techniques until the risks associated with them are clear. The potential for disaster is immense, and we shouldn't be gambling with the future health and future environment of the Australian nation! We need the government to ensure that OGTR and FSANZ are reformed so as to become proper regulators -ones that will protect the Australian public from potential disaster, rather than just implement the desires of the GM industry. I think it would be a really magnificent day for Australia if OGTR and FSANZ would act like proper regulators, rather than simply just carry out the wishes of the GM industry! The issue of genetically-modified-organisms is really important, and the issue of new GM techniques is really important.
I'm so sick of OGTR and FSANZ and governments letting the country down when it comes to the GM issue. It is vital that OGTR and FSANZ and the federal government don't let us down again when it comes to the new GM techniques that I've referred to. The precautionary principle must prevail, and the health and environment of Australians must be safeguarded! Thank you for ensuring this takes place.
Trevor Anton / Please do not make any changes to the Gene Technology Regulations. You have no idea how dangerous GMO in plants are and in human consumption.
In the earlier days of GMO in plants a small group of scientist wanted to promote changing genes in plants. They lied and cheated to get they way and fooled many high ranking government official in the US. They lied to the majority of scientist who were wanted more testing done – they never did. any safety testing. The FDA own scientist recommended that GMO food should not be sold to the public. The FDA never listened.
If you want the history of how all this started I recommend you read the book ‘Altered Genes, Twisted Truth’ by Steven M . Druker, published by Clear River Press USA Steven Druker is a lawyer who was first involve with GMO in the nineties.
I have been following the GMO debate since 1995 and you would not believe how much untruths have come out of the scientist of these GMO multi nationals.
So please don't make any changes to the Gene Technology Regulations.
Reviews commissioned by the Austrian and Norwegian governments concluded that not enough is known about the risks posed by these new GM techniques. They recommended that products derived from them require comprehensive case-by-case risk assessments.
Auckland GEFree Coalition / This further submission is made by the Auckland GE-Free Coalition, a network of concerned community members and groups seeking regulation and preservation of the right to choose non-modified products.
It is imperative that the Office of the Gene Technology Regulator regulates new GM techniques or there will be no monitoring or surveillance, no capacity to diagnose emerging issues and no ability for rapid remediation: you will be operating in the dark.
There is evidence that CRISPR, RNAi, gene drives and all other new techniques have unexpected consequences in the process.

These consequences may or not be harmful but MUST be subject to oversight and regulation.
These techniques are GM and even if not transgenic, they raise comparable issues in the context of incomplete knowledge of complex genetic systems.
The new GM techniques need safety assessments, regulation, labelling and monitoring.
Moreover, developers and users of these techniques must be fully liable, for their products and actions. This may help encourage moderation of extreme risk-taking.
The Australian Department of Health has advised the WTO of its proposal to change the Gene Technology Act.This raises concern that the opportunity to acknowledge these new technologies are GM will be removed and will close down public and independent scientific discussion of precaution and alternatives.
It is spurious to argue that chemical or other kinds of mutagenesis are not regulated, so nor should new GM techniques be.The historical context is different and if we knew then what we know now, caution should have been applied to those techniques.
Regulation is the only legitimate starting point,as it can be adjusted in future. No regulation allows a shoot-out in a genetic ‘wild west’ that cannot possibly be in the public or national interest.
Kathy Austin / I am amazed that our leaders could even consider deregulating living GM products.
Are they deliberately trying to destroy our food supply, are they naive or just in love with any new scientific skill, regardless of side effects?
Where is the long term health safety testing for both humans, who consume the products, and animals themselves? It has not been done.
Australians need quality food to live a health life. Please do not remove our choice in the midst of a food market already full of added chemicals. This is not a free country if we do not have the freedom to chose healthy foods.
Pauline Abbonizio / Why is the Australian Government rushing to be the first in the world to deregulate some new genetic modification techniques in animals,plants and microbes ?
What has happened to CSIRO ??
They did wonderful work to keep Australians strong, fit and healthy. Sometimes, they took years of testing before new techniques were allowed to be accepted and used in Australia.
What has happened to change this process ??
Susan Ablitt / I support Option 3: amend the GT Regulations with some but not all of the draft amendment proposals.
I support the repeal of item 1 in Schedule 1. Organisms that have been altered by gene technology should be regulated as GMOs, irrespective of whether any ‘foreign nucleic acid’ has been introduced.
‘Gene editing’ techniques
I oppose the proposed deregulation of GM techniques such CRISPR (SDN-1) when used to make naturally repaired DNA breaks.
If these techniques are deregulated there will be no monitoring or surveillance. Anyone from amateur biohackers, to industry, to terror groups would be free to use them to genetically modify plants, animals and microbes. Entirely new diseases and poisons could be made. And they could enter our food chain and our environment with no safety testing and no labelling. The risks are enormous and the results could be catastrophic.
CRISPR has only been used for genetic engineering for the past 5 years. Reviews commissioned by the Austrian and Norwegian governments concluded that not enough is known about the risks posed by new GM techniques such as CRISPR. They recommended that products derived from these techniques require comprehensive case-by-case risk assessments.
Deregulating techniques such as CRISPR, given the knowledge gaps that exist around the risks they pose is completely at odds with the Precautionary Principle embedded in the Gene Technology Act.
All of these techniques result in unpredicted mutations that can result in the production of toxins and allergens.
Your argument that these techniques create similar results to chemical and radiation mutagenesis which have a history of safe use does not stand up to scrutiny. Neither of these techniques have been safely used in animals or microbes.
Even small changes to the DNA of microbes can result in large differences in pathogenicity. Deregulating the use of these techniques in microbes poses major biosafety risks.
The deregulation of these techniques in animals could lead to a large increase in animal experimentation, raising major ethical issues. The unintended mutations caused by these techniques could pose serious potential animal welfare concerns.
Unlike chemical and radiation mutagenesis which increase the rate of random mutation, all of these techniques can be used sequentially to make dramatic changes to the genome.
Your argument that these mutations could occur naturally and therefore don’t need to be regulated is disingenuous, since the natural mutation rate is extremely low. One plant study found that the probability of any letter of the genome changing in a single generation is about one in 140 million. In contrast these new GM techniques can cause hundreds of unwanted mutations in some organisms.
Chemical and radiation mutagenesis could also result in the production of allergens and toxins and should be regulated. Arguing that new techniques such as CRISPR should be deregulated because of the Government’s failure to regulate other potentially risky techniques sets a dangerous precedent.
All of these techniques rely on older GM methods such as protoplast creation, biolistics, viruses, electroporation tissue culture, and Agrobacterium-mediated gene transfer. These can all cause unexpected mutations that would be extremely unlikely to occur in nature. This is why organisms produced using them need to be assessed for safety.
All of the new GM techniques can result in the accidental incorporation of bacterial or synthetic DNA into the chromosome. With no regulation, these unexpected effects won’t be looked for.
Your claim that organisms modified using these techniques would be indistinguishable from natural organisms and so regulation would be unenforceable is nonsensical. Existing SDN-1 products such non-browning mushrooms are patented – requiring full molecular characterisation and enabling traceability. Even if this information isn’t available there are a number of techniques that can be used to identify organisms produced using SDN-1.
Null segregants
I oppose the deregulation of ‘null segregants’ – the offspring of GMOs which supposedly no longer contain any GM DNA. This is an assumption that needs to be tested via regulation involving full molecular characterisation. The definition of a GMO in Australia should include organisms derived from GMOs, or those that include temporal GMOs, as is the case in the EU.
RNA interference and gene silencing
I oppose the proposed deregulation of RNA interference and gene silencing.
The Australian Gene Technology Act defines gene technology as “any technique for the modification of genes or other genetic material”. This definition clearly includes RNA interference and gene silencing.
There are well-founded concerns that non-target organism could be adversely affected if RNA interference is used as a crop protectant against insect pests. This is the case whether the RNAi is topically applied, or produced via a GMO. Therefore, it is essential that all applications of RNAi within the environment undergo a risk assessment (i.e. are regulated).
Gene drives
Gene drives pose potentially catastrophic environmental consequences and any research should be conducted in the most secure and stringent containment facilities (PC level 4).
There should be a moratorium on the environmental release of gene drives.
Mick Alexander / The primary aim of this review is to provide clarity about whether organisms developed using a range of new technologies are subject to regulation as genetically modified organisms (GMOs) and ensure that new technologies are regulated in a manner commensurate with the risks they pose. “The definition of ‘genetically modified organism’ in the GT Act was intentionally cast very broadly to ensure that the definition did not become outdated and ineffectual in response to rapidly changing technology.” And now the OGTR is wanting to narrow down the definition? Why would anyone want to reduce the impact of the act? At this point in time, we have no idea as to the risk being posed by any GM technology as no GM product is being tested for long term chronic impact. The industry is attempting to sneak amendments through without any scrutiny, so that corporates can push potentially harmful GM products onto unsuspecting families without their knowledge. I oppose any changes to the Gene Technology Act which reduce the accountability required by either the regulator and or corporate entities involved in the development of GM products. Our families health and the environment is far more important than the profits of multi-nationals who only care is the bottom line.
  1. Which option/s do you support, and why?
• I support Option 1: no amendment to the GT Regulations. This option will ensure that all GM products are treated in the same manner and scrutinised by the regulators to ensure they are safe. The GM definition will include all processes which are undertaken in a laboratory to alter the genetic makeup of an organism. It will also ensure that the backyard GM hackers cannot accidentally or on purpose create diseases or other mutations. This option is the only safe option for Australia.
  1. Are there other risks and benefits of each option that are not identified in this document?
Option 1 – Benefits • The major benefit to option 1 is to ensure that all GM technology is assessed/ scrutinised fully and that only the safest of these new products are brought to market. No GM technology has ever been proven safe for long term human consumption or undergone long term feeding trials to demonstrate safety. At least option 1 will ensure that FSANZ will also treat the GM product as a novel product and not simply ignore potential harm.
  1. Is there any scientific evidence that any of options 2-4 would result in a level of regulation not commensurate with risks posed by gene technology?
• Options 2 – 4 are open to individual choice by the regulator and biases to be imposed by individuals involved.
  1. How might options 2-4 change the regulatory burden on you from the gene technology regulatory scheme?
• Options 2-4 are all about excluding new technologies etc. By definition, they describe all new technologies which are not well known even in the scientific industry. How could we as a nation simply agree it is ok to approve this technology because a scientist tells us it is safe. Where is the evidence of safety? • Options 2-4 would make it very easy for GM products to be approved without any safety testing. It would reduce the workload of the regulator. If the regulator simply wants less work, then the regulator should find another job and we should employ more enthusiastic and committed staff. • If options 2-4 were accepted, scientists and corporates would actually have to show the burden of proof that their product is actually safe for our families.
  1. How do you use item 1 of Schedule 1, and would it impact you if this item was changed?
• I support the repeal of item 1 in Schedule 1. Organisms that have been altered by any form of gene technology should be regulated as GMOs, irrespective of whether any ‘foreign nucleic acid’ has been introduced. Scientists still do not understand the potential unintended impacts of any changes they are making to the genome and so cannot know the true outcome until the changes are tested for chronic impact under long term trials.