No new genetic material, no regulation, no problems?

What you need to know

• In November 2019, there was a failed Senate motion to disallow the Gene Technology Amendment (2019 Measures No. 1) Regulations 2019 (Cth) (the Amendment Regulations), which deregulate the use of certain gene editing techniques. 
• A distinction is now drawn between: (i) gene editing techniques that involve targeted cutting of cellular DNA without the introduction of foreign DNA, which are no longer regulated; and (ii) gene editing techniques that involve targeted cutting of cellular DNA and the introduction of foreign template DNA, which continue to be regulated by the Office of Gene Technology Regulator (OGTR).    
• It is uncertain what impact the Amendment Regulations will have on Australia's export of produce labelled as "GMO free" to countries with more stringent regulatory regimes. 

Genetically Modified Organisms, or GMOs, are regulated under the Gene Technology Act 2000 (Cth) (the Act).  

GMO is defined broadly under the Act to include any organism that has been modified by gene technology.  The Act also provides for organisms and classes of organisms to be declared GMOs, or alternatively excluded from being GMOs, under the Gene Technology Regulations 2001 (Cth).

The Amendment Regulations

The Amendment Regulations exclude the following class of organisms from the definition of GMO: 

"An organism modified by repair of single-strand or double-strand breaks of genomic DNA induced by a site-directed nuclease, if a nucleic acid template was not added to guide homology-directed repair"

The genetic modifications described in the above definition are known as "SDN-1" modifications.  "SDN", or "site-directed nuclease", refers to an enzyme that is used to cut a DNA sequence at a predetermined location.  

SDN-1 modifications involve the introduction of a break in the DNA of an organism, without the introduction of a nucleic acid template to assist in DNA repair.  SDN-1 modifications are used to "knock-out" or silence unwanted genes.  For example, SDN-1 modifications have been used to generate disease-resistant rice, and mushrooms in which the gene coding for the enzyme which causes browning has been knocked-out.    

Because SDN-1 modifications do not involve the introduction of nucleic acid templates to assist in DNA repair, no "new" or "foreign" DNA sequences are introduced into the genome of an SDN-1 modified organism.   

SDN-1 modifications can be distinguished from SDN-2 and SDN-3 modifications.  SDN-2 and SDN-3 modifications are also brought about by site-directed nucleases, but involve the use of nucleic acid templates to introduce "new" or "foreign" DNA sequences or genes into the genome of the organism.

Rationale for the amendments   

According to the Explanatory Memorandum, the Amendment Regulations were intended to ensure that GMOs are classified appropriately according to current scientific understanding, which suggests that genes edited through SDN-1 do not pose any different risks from natural mutations.  

The exclusion of SDN-1 modified organisms from the definition of GMO is intended to promote more efficient and cost-effective uses of new gene editing technologies.  This will help scientists research, develop and bring to market improved products, such as crops that could improve agricultural productivity. 

Opposition to the amendments and the Senate vote

The amendments were contentious, with Greens Senator Janet Rice tabling a motion in August 2019 to disallow the Amendment Regulations.  Senator Rice contended that, as a result of the amendments, Australia's definition of GMO would be inconsistent with that of other international jurisdictions, including some of Australia's trading partners.  This would mean that products designated "non-GMO" and "organic" in Australia would not be able to maintain that designation in some other markets.  Senator Rice also cited concerns for the safety of consumers of food products, and emphasised her belief for the need for regulatory oversight.  Senator Rice had the support of Gene Ethics, Friends of the Earth and Slow Food Hunter Valley.  

However, the amendments had bipartisan support from the Coalition and Labor parties, and on 13 November 2019, the Senate debated and defeated the motion to disallow.  As a result, the Amendment Regulations remain in effect.  

In support of the amendments, Coalition and Labor Senators emphasised the fact that the amendments were rigorously considered by the OGTR, were supported by the weight of available scientific evidence, and would benefit the majority of Australians by allowing unnecessarily regulated access to emerging technologies.  Their opposition to Senator Rice's motion was also supported by the Australian National University, the Australian Academy of Science, the Australian Academy of Technology, the Association of Australian Medical Research Institutes and Australian Dairy Farmers. 

Global context 

Post-amendments, the Australian position is a "middle ground" between more lenient gene-editing rules in the United States, Brazil and Argentina, and tougher measures in the European Union.  In the European Union, the most recent decision from the European Court of Justice affirmed that all SDN techniques are considered to be genetic modification techniques, and require regulation.

The breadth of scientific evidence supports the safety and utility of SDN-1 modification technologies.  However, from an international perspective, the lack of inter-jurisdictional uniformity in the definition of GMO raises concerns that some of Australia's major export markets will now reject Australian-certified "GMO-free" produce.