In brief 9 min read
As gene technologies advance, regulatory certainty is paramount. The Federal Government has amended the scheme that regulates the release of genetically modified organisms into the environment in a manner that is commensurate with risk. However, regulating the supply of genetically modified foods is a separate piece of the puzzle and a proposal to amend the Food Standards Code, if any, is pending subject to its review. Senior Associate Lauren John and Lawyer Artemis (Tess) Kirkinis report.
- The Government's amendments to the National Gene Technology Scheme provide new opportunities for agribusinesses to utilise advancements in gene technology to develop high-quality products.
- Gene technologies that involve the use of foreign template nucleic acid will continue to be regulated as genetically modified organisms. However, the regulation of a variety of specific gene technologies that do not involve the insertion of foreign DNA has been clarified.
- The Food Standards Code, which regulates the supply of genetically modified food, has not been updated since it was introduced almost 20 years ago and is currently being reviewed.
these technologies pose a challenge for Australian gene technology and related regulations, which have not kept pace with technological change.
The use of gene editing and other gene technologies is widespread in the agribusiness sector, and as global food demand and the need for yield gains increase, taking advantage of crop breeding using gene technology has never been more important. This is particularly the case as significant advancements in the field of gene technology in recent years have led to improvements in the quality, sustainability and productivity of agricultural products, including foods. CRISPR, a tool that allows the editing of genes with a high degree of accuracy, is one example of a (relatively) recent form of gene technology that has garnered much attention in the press. While advancements in gene technologies allow scientists to more easily and efficiently target traits of interest in food products, these technologies pose a challenge for Australian gene technology and related regulations, which have not kept pace with technological change.
In the face of legal uncertainty about the regulation of these new technologies, the question of if, and how, such uses of CRISPR, and other similar gene technologies, should be regulated was a key consideration of the recent Third Review of the National Gene Technology Scheme (the Scheme) and the Technical Review of the Gene Technology Regulations 2001 (Cth) (the Regulations). The Scheme is designed to protect the health and safety of people and the environment from the risks associated with gene technology.
On 8 April 2019, the Federal Government announced that the Gene Technology Regulator (the Regulator) will no longer regulate the use of gene-editing techniques in plants, animals and human cell lines that do not introduce new genetic material. However, when it comes to the regulation of genetically modified foods, the Scheme is only one piece of the regulatory puzzle. All genetically modified foods intended for sale in Australia and New Zealand must undergo a safety assessment by Food Standards Australia New Zealand (FSANZ). Such foods are regulated under Standard 1.5.2 in the Food Standards Code (the Code), which has not been updated since it was introduced almost 20 years ago, but is currently being reviewed.
The Gene Technology Act 2000 (Cth) (the Act), which is part of the Scheme, manages the risks associated with gene technology by regulating all dealings with genetically modified organisms (GMOs) and any dealing with a genetically modified product (GM product) not already covered by existing regulatory agencies (eg FSANZ or the Therapeutic Goods Administration). This includes dealings involving the intentional release of a GMO into the environment.
Currently, for an organism to be regulated under the Scheme it must first meet the definition of a GMO under the Act. The definition of a GMO includes:
- an organism that has been modified by gene technology;
- an organism that has inherited particular traits from an organism (the initial organism), being traits that occurred in the initial organism because of gene technology; or
- anything declared by the Regulations to be a GMO.
Schedule 1 of the Regulations excludes a range of organisms from the definition of GMO, including ʻa mutant organism in which the mutational event did not involve the introduction of any foreign nucleic acid (that is, non-homologous DNA, usually from another species)’. A GM product is a thing (other than a GMO) derived or produced from a GMO.
When the Act and Regulations were originally drafted, gene technology was primarily used to move genes from one species to another. This is no longer the case. For example, CRISPR is an adaptable technique that can be used to insert foreign DNA into an organism (thereby creating a GMO), but can also be used to produce organisms that are genetically identical to organisms that occur in nature or from conventional (and non-regulated) breeding techniques.
Amendments to the Regulations
On 10 April 2019, the Regulations were amended by the Gene Technology Amendment (2019 Measures No. 1) Regulations 2019 to ʻensure that certain dealings with GMOs continue to be classified appropriately according to current scientific understanding of risks which they may impose’ (see Explanatory Memorandum). These amendments, which come into effect on 8 October 2019, clarify the meaning of GMO under the Act. They do not impact current requirements for genetically modified food under the Code.
The amendments specifically address three forms of gene technology that are used for altering genetic sequences and gene expression – site-directed nuclease (SDN) techniques, oligonucleotide-directed mutagenesis, and RNA interference techniques – which are not addressed in explicit terms in the current Regulations.
Organisms that are GMOs
The decision of the Regulator arising from the Technical Review was that organisms produced by technologies that involve the use of 'foreign' template nucleic acid to direct the repair cleaved nucleic acid, or that insert foreign DNA into an existing genome, such as SDN-2, SDN-3, oligonucleotide-directed mutagenesis and some CRISPR techniques, will continue to be regulated as GMOs (see new Schedule 1B of the amended Regulations).
Organisms that are not GMOs
The decision of the Regulator arising from the Technical Review was that genetic changes brought about through SDN-1 are no different to natural mutations and, therefore, do not give rise to any different risks to natural mutations. Consequently, Schedule 1 of the Regulations will be amended to clarify that organisms modified using SDN-1 techniques are excluded from the definition of GMO in the Act. Schedule 1 will also be amended to include organisms that are derived from GMOs that have not inherited traits brought about by gene technology (null segregants), and organisms that previously were temporarily modified by gene technology, but the modification and any resulting traits are no longer present.
Techniques that not gene technology
Schedule 1A of the Regulations, which declares that certain techniques are not gene technology, will be amended to include certain interference RNA techniques (eg gene silencing), provided that: the RNA cannot be translated into a protein, the organism’s genome sequence is not altered as a result, and an infectious agent cannot be produced. This means organisms modified using these techniques will not be classified as GMOs. However, RNA interference techniques which involve inserting sequences into the genome or use of viral vectors will continue to result in GMOs which are subject to regulation.
Consequences for agribusinesses: greater investment and enhanced innovation
The Australian position represents a middle ground between permissive gene-editing rules in the United States and the particularly strict approach taken by the European Union following the European Court of Justice (Case C-528/16) ruling that organisms obtained by directed mutagenesis are to be regarded as GMOs.
The relaxation of the Regulations means that agribusinesses, together with developers, researchers and others, can utilise these advancements in gene technology to develop, produce, manufacture and grow high-quality agricultural products without regulatory oversight. Large-scale use of such gene technologies in the agribusiness sector may also improve efficiencies and drive down costs. In addition, the changes may encourage greater investment in these technologies and products resulting from their application, which is likely to enhance innovation in the agribusiness sector.
Standard 1.5.2 regulates the supply of food produced using gene technology. The standard has two provisions – mandatory pre-market approval (including a food safety assessment) and mandatory labelling requirements.
The Code uses a different definition of ʻgene technology’ than the Act and Regulations. Specifically, under Standard 1.1.2‒2, ʻfood produced using gene technology’ means a food which has been derived or developed from an organism that has been modified by gene technology, where ʻgene technology’ means recombinant DNA techniques that alter the heritable genetic material of living cells or organisms. Although the term ʻrecombinant DNA techniques’ is undefined, FSANZ says the practical effect of the definition has been the capture of foods derived from organisms that contain new pieces of DNA in their genome derived from any source, including the same species. As part of the Third Review of the Scheme, FSANZ submitted that despite the definitional differences, ʻthere have been consistent regulatory outcomes to date’.
FSANZ is reviewing the Code
In February 2018, FSANZ released a consultation paper seeking feedback from the community on whether food derived from three categories of new breeding techniques (NBTs) should be captured for pre-market safety assessment approval under Standard 1.5.2, and whether the definitions for ʻfood produced using gene technology’ and ʻgene technology’ in Standard 1.1.2‒2 should be changed to improve clarity about which foods require pre-market approval.
The NBTs in the first category involve the introduction of new DNA into the genome which remains in the organism from which food for sale is obtained. This can result from transgenesis (introducing foreign DNA from a different species), cisgenesis (introducing genes from the same species) or intragenesis (introducing DNA from the same species). FSANZ considered that the capture of food derived from organisms with new DNA inserted would be consistent with the types of foods already requiring approval.
The NBTs in the second category are those where DNA is inserted into an initial organism but is not present in the final organism from which food for sale is obtained (ie producing null segregants). As mentioned above, null segregants will no longer be GMOs under the Regulations. The NBTs in the third category are those where changes are made to the existing genome, but no new DNA is present in the organism from which food for sale is obtained (ie new plant varieties developed using CRISPR gene-editing technology that does not involve the insertion of foreign DNA). The NBTs in these categories are unlikely to be captured by the current definitions in the Code.
While the consultation revealed that views are divided about the risks or safety of food derived from NBTs, there was consensus among stakeholders that greater clarity is needed in terms of what foods are captured for pre-market assessment and approval. Several stakeholders expressed concerns that the definitions in the Code are no longer fit for purpose, with some suggesting the definitions should be aligned with those used in the Act.
FSANZ is still considering the consultation outcomes and intends to issue a final report later this year, including its recommendations on whether to prepare a proposal to amend the Code.
As gene technologies continue to advance, legal certainty is paramount. Although the Regulations have been amended to ensure new gene technologies are regulated in a manner commensurate with the risks they pose, we will have to watch this space to see what (if any) changes are in store for the Code.