**2. Issues**

#### **2.1 Regulation of GM crops in Australia**

The National Gene Technology Scheme (NGTS) in Australia was enabled by the Gene Technology Act 2000. Regulation is administered by the Office of the Gene Technology Regulator (OGTR), to apply a process based 'Precautionary' approach to any kind of directed genetic alteration [1, 11], specifically DNA transfer between species.

The object of the Act for all living organisms is: *'To protect the health and safety of people, and to protect the environment, by identifying risks posed by gene technology, and by managing those risks through regulating 'dealings' with GMOs'.*

OGTR authorises the release of GM crops in coordination with other agencies; Food Safety Australia and New Zealand (FSANZ), the Australian Pesticides and Veterinary Medicines Authority, Therapeutic Goods Administration, National Industrial Chemical Notification and Assessment Scheme, Department of Agriculture and Water Resources, and Department of the Environment and Energy [11, 12].

CRISPR Genome Editing (GE) is able to alter genetic expression without transfer of new genetic material with the SDN1 procedure, as a more advanced version of GM. OGTR has made a recent incremental change to a 'Principles based' flexible approach, with recognition of the SDN 1 with a product history of low risk [4, 11, 12]. However OGTR risk assessment and oversight remain, plus the regulations of complementary agencies.

SDN 1 genome editing is classified as GM/GE under 'Notifiable Low Risk Dealings' (NLRD) [11, 12]. NLRD products cannot be released to the environment without OGTR approval, and must be compliant with OGTR regulations for transport, storage and disposal, while GM field trials have to be registered and isolated [11]. NLRDs must be approved by the Institutional Biosafety Committee (IBC) and OGTR [11, 12]. Costs apply for administration, risk assessment and management.

OGTR requires that GM/GE crop development must undergo detailed case-bycase assessment of risks to food safety and to the environment, with research and development conducted in contained facilities; this is expensive research [13, 14]. This is based on the 'Precautionary' principle, rather than 'Outcome' based with recognition of benefits to society and the environment.

The science of gene technology is poorly understood publicly, enabling the Green lobby to demonise GM for socio-economic reasons or to challenge details of a scientific study [15, 16], or now to raise fears that SDN 1 GE is GM in disguise, so allowing GM foods to be unlabelled and hidden from the public [17, 18].

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

The anti-GM lobby is well funded in USA through tax deductions to 'organic' and environmental groups [19, 20]. Anti-GM protesters have destroyed GM field trials in UK and Australia, and with non-scientific health and environmental claims supported risk regulation of GM crops and discouraged developing countries from approving GM crops [18, 19, 21, 22]. Organic certification demands no GM products, so that the organic industry has a large vested interest in denigrating GM.

Foods derived from GM crops pose no greater safety risk than from conventional plant breeding [2, 4, 5, 23, 24]. GM food safety has been validated with over 25 years of research by the American Medical Association [25], World Health Organisation [26], The British Royal Society [27], and 500+ independent institutions. GM crops benefit the environment primarily by substantially reducing the use of toxic pesticides/fungicides [28].

#### **2.2 Genome editing (GE)**

The new GE techniques such as CRISPR enable precise changes to the genome, with cutting of DNA at a specific location, and insertion, deletion, or modification of nucleotides in a gene, and include gene silencing, gene enhancement, and synthetic genes (**Figure 1**) [4, 29, 30].

China has heavily invested in GE with the purchase of Syngenta [31]. Genome editing has been developed for tomato, potato, maize, rice, wheat, sorghum and citrus, and presents a major challenge to GM crop regulators [4]. GE dramatically increases the number of traits which can be modified in crops, in a manner which is far quicker and cheaper than the original GM technology has been able to achieve [30, 32].

Base pair alteration (SDN 1) may be indistinguishable from either a random mutation or what may be achieved by conventional breeding, and is regarded as very low risk for health and the environment [4]. It is unlikely however to replace most uses of GM from before 2010 and already in farmers' fields. The SDN 2 CRISPR procedure involves larger DNA changes with a DNA repair template, while

#### **Figure 1.**

*Image adapted from source U.S. Food and Drug Administration [29].*

SDN 3 enables targeted insertion of foreign DNA, both are still subject to full OGTR regulation.

The CRISPR-Cas9 DNA insertion is displayed in **Figure 2** [29].

Occurrences of 'off-target' changes are very rare in plants and detectable by whole genome sequencing [4]. Mutation breeding has always been exempt from regulations, a precedent for SDN 1 GE.
