Here are some suggested points you could make in your submission:

General points

• 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.