**2.3 GM regulation and GE**

Policies on GM regulation are evolving with changes in biotechnology, but at different rates and to different extents in various countries. Genome editing targets the introduced traits themselves rather than the technology used to create them, in contrast to the traditional process-triggered GM regulatory system championed by Europeans [13, 33, 34]. EU does not exempt GE from GM regulations [4, 35].

In recent national responses to advances in GE [36]; USA, Norway, Australia, New Zealand, Japan, and Argentina either permit SDN 1 genetic changes, or are considering relaxation of regulation. Lassoued *et al.* [37] reviewed plant breeders on deregulation of GE, who noted increased ease of transformation, gain in precision, and improved opportunity to introduce novel traits from Crop Wild Relatives (CWR) through GE. Public education about GE was seen as necessary, plus opportunity for public participation in legislative processes to relax regulations [38]. New regulatory frameworks have been proposed [39–42], with the latter suggesting a product based approach for regulation of GE crops, especially now that genome sequencing is complete for over 200 plants and under development for over 10,000 genome assemblies.

Agribio Victoria can process 50,000 SNPs at a time, and has sequencing capabilities for reliable detection of interactions between large numbers of different genes. These affect the majority of traits of agricultural interest, and can be a significant complement to the expression of major genes such as 'blackleg' resistance in canola [43]. The advances in sequencing and in GE together make possible the targeted transfer of complex abiotic stress tolerance traits from CWR to domestic crops.

#### **Figure 2.**

*A Schematic diagram of the Cas9 enzyme (yellow) and the guide RNA (gRNA) that directs the enzyme to cleave double-stranded DNA (dsDNA) at specific sites. Image adapted from source: Marus Walter, Attribution-share alike 4.0 International (CC BY-SA 4.0).*

However worldwide acceptance of revised regulations would be needed to achieve international consensus and removal of asynchronous trade barriers [44–46], which are significant barriers to international commercialisation of GM/ GE [47, 48].

Future challenges include a warmer more variable climate for which CRW can provide genes for abiotic and biotic stress tolerances [40, 41, 49]. In many cases biotechnology applications can assist introgression of these stress tolerant traits into crops [4]. This would help to address twin challenges to agriculture of climate change and food security for a predicted 10 billion people by 2060 [50].

### **2.4 Climate change and genetic adaptation**

World food security has become severely threatened since the introduction of regulations on gene technology for crops over 20 years ago [1]. Gene technology regulation needs to recognise that crop environments are becoming more variable and challenging. There has been an unprecedented growth in world population by over three-fold in the last 100 years to 7.85 billion today [50], with an equally dramatic 60% rise in the greenhouse gases, especially CO2 mainly from coal, oil, gas and cement sources of pollution to over 400 ppm [51], resulting in a continual but fluctuating increase in global mean temperature towards 1.5°C above pre-industrial levels since 1900 [51]. On most scenarios this warming will rise above 2°C by 2100, with the lowest emission scenario very unlikely to eventuate, with increasing urbanisation and more energy intensive life styles. Certain trends such as polar warming can set up reinforcing feedback loops for warming: ice melts, permafrost thaws, and desertification. Spikes in high temperature will be from a higher base, and frosts and droughts will be more severe especially upon seed set. Food security will be under threat [30, 49].

Thus a climate crisis for agriculture has intensified since the 1990s, when genetic modification of food and fibre crops raised safety concerns. However GM crops have been shown to be beneficial with improvements in crop and food nutrition, disease and pest resistances, yield productivity, and tolerances of drought, high temperature, frost and salinity [4].

Now in the 2020s there is an urgent need to widen the genetic diversity of food and fibre crops to address the coming challenges of abiotic and biotic crop stresses with Climate Change [30, 41, 49]. GE provides the tools to exploit the largely untapped genetic diversity of CWR, the evolutionary ancestors of crops [17, 30], with precise introgression of genes for abiotic/biotic tolerances (heat, frost, and drought tolerances, salinity, pest and disease resistances). CWR have genetic diversity for adaptation to far more extreme environments than crops were exposed to during domestication over the past 12,000 years, and provide opportunities to transform crop adaptation to Climate Change [17, 52]. However it is an immense challenge to implement GE transformations across all crops; from vegetables, spices, cereals and legumes to root crops and fruits, before the world is stranded with agricultural systems un-adapted to changed environments.

There is a future opportunity cost in not recognising that climate change combined with an unprecedented growth in population creates an urgency to re-adjust GM regulation, to promotion and acceptance of new gene technologies, especially GE [16, 29, 45, 53–55]. NGTS can re-align towards an aspiration of crop adaptation (climate proofing) to climate change [24, 39]. Advances in cropping ingenuity and crop genetics will be essential to produce more food in more hostile environments.

#### **2.5 Proposal for a revised NGTS for food and fibre crops only, in Australia**

An appropriate tiering of regulation for crops should recognise outcomes of product benefits to farming and the environment, and a long established food safety record.

GM/GE food and fibre crops should be exempt from NGTS regulation [1]. The current NGTS/OGTR over-regulation stifles the opportunity to realise the benefits from CWR for adaptation to climate change, raises costs, and tends to exclude GM/GE research and development from small research organisations. The present costs to market for GM/GE crops are prohibitive [16]. The current NGTS/OGTR regulations are no longer fit for purpose, and NGTS could be changed to exempt food and fibre crops only, but not vaccine and pharmaceutical crops, microorganisms and animals [1, 11].

A Revised NGTS [1] for food and fibre crops would have a new aim: '*Genetic improvement of food and fibre crops by application of gene technologies, with recognition of product outcomes of agricultural, health and environmental benefits'*.

This Revised NGTS would greatly reduce operational costs of the plant-centric OGTR and better secure its funding sustainability, without the monitoring, surveillance and compliance activities for GM/GE food and fibre crops.

A restructured OGTR could change from regulating GM food and fibre crops, to play a major role in educating the public on the benefits of new biotechnologies with publications, educational webinars and social media posts [1]. OGTR has the required expertise to explain and illustrate new developments in biotechnology [11, 12]. This could be supported with championing of a Revised NGTS for food security in a more populous world with a changing climate.

### **3. Summary of a proposed revision of NGTS for crops in Australia**

OGTR regulations on GM food and fibre crops need to be removed for equivalence with conventionally bred crops. The proposal is for an exemption of GM food and fibre crops from current NGTS regulation, and adoption of a Revised NGTS for sustainability of agriculture under climate change.

As proposed by Redden [1], a Revised NGTS would include:


*Proposed Revision of the National Gene Technology Scheme for Australia DOI: http://dx.doi.org/10.5772/intechopen.99966*

