Current regulatory status

The rapid advances in gene editing and gene drive technologies present substantial challenges to current regulatory systems that are under active consideration in numerous jurisdictions (Nuffield, 2016; NAS, 2016a; Secretariat CBD, 2015). There are important differences between gene editing and gene drives. As organisms with a gene drive may spread beyond geographical borders, this raises many questions including who should, ultimately, make the final decision on a gene drive release? And who bears responsibility for any negative consequences?

The ability of gene drives to intentionally spread a trait through a population carries important implications for the governance of gene drive research, not only for the regulatory framework but also the informal processes of implementing a gene drive. The informal processes include public engagement, addressing societal expectations, communication, and mitigation strategies which have been discussed in the previous sections.

Australia has a well established regulatory framework for gene technology. Our national, integrated regulatory scheme is a process-based system that was set up to protect people and the environment by identifying and managing the risks posed by live and viable GMOs. The Gene Technology Act 2000 (the Act) covers work with GMOs in certified contained laboratory conditions as well as intentional releases to the environment under limited and controlled conditions (field trials), through to unrestricted releases.

Where gene technology is used to introduce or create a gene drive in an organism, the resulting organism will be considered to be a GMO and subject to regulation under the Act.7 Hence, the use of site-directed nucleases (SDNs) such as CRISPR/Cas9 to produce a gene drive modified organism would be regulated.

To enhance coordinated decision making and avoid duplication, the Act requires consultation between regulatory agencies that have complementary legal responsibilities and expertise in relation to the evaluation and use of GMOs and GM products (Table 2).

Where a synthetic gene drive modified organism targets invasive species, a range of legislative provisions may also apply. The Biological Control Act 1984 (Commonwealth) assesses and authorises biological control activities. Each state and territory has their own version of this act (except the ACT, which is under the Commonwealth act). As such organisms can potentially cross state and territory borders, agreement across Australia will be needed for the release of a synthetic gene drive modified organism to control invasive organisms. In addition, the Biosecurity Act 2015 targets biosecurity risks entering Australia from overseas relating to animal and plant pests and diseases so a gene drive modified organism imported from overseas would likely be subject to this act. The Environmental Protection and Biodiversity Conservation Act 1999 (EPBC), which protects and manages nationally and internationally important flora, fauna, ecological communities and heritage places, may also need to be considered.

Table 2: Australian regulatory environment for GMOs
Agency Relevant legislation Scope
Office of the Gene Technology Regulator Gene Technology Act 2000 Genetically modified organisms, including gene drives.
Department of Agriculture and Water Resources Biological Control Act 1984

Biosecurity Act 2015
Assessment and authorisation of biological control activities.

Assessment and management of biosecurity risks from diseases and pests. Includes provisions addressing importation of products presenting a biosecurity risk.
Department of the Environment and Energy Environmental Protection and Biodiversity Conservation Act 1999 Protection and management of nationally and internationally important flora, fauna, ecological communities and heritage places.
Australian Pesticides and Veterinary Medicines Authority Agricultural and Veterinary Chemicals (Code) Act 1994 Agricultural and Veterinary Chemicals Administration Act 1994 Agricultural pesticides and veterinary medicines.
Food Standards Australia and New Zealand Food Standards Australia New Zealand Act 1991 Food and food technology (including food produced using gene technology).
Therapeutic Goods Administration Therapeutic Goods Act 1989 Human therapeutics, including medicines and medical technologies.

Some work with gene editing and gene drive technologies may be subject to control as a consequence of Australia’s membership of a number of international counter-proliferation regimes. The Defence Trade Controls Act was introduced in 2012 to prevent sensitive goods and technologies that could be used for offensive purposes (known as ‘dual use’) going to individuals, states or groups of concern.

The regulatory environment continues to evolve in response to changes in technologies. At the time of writing The Gene Technology Regulator, the independent statutory office holder responsible for administering the Gene Technology Act 2000, is conducting a technical review of the Gene Technology Regulations 2001, with community consultation and engagement. This review is explicitly considering gene drive technology. The Department of Health will be undertaking a scheduled review of the Gene Technology Act 2000 in 2017, and Food Standards Australia and New Zealand has commenced a review to consider food derived using new breeding techniques, including gene editing technologies.

Australia also works with other countries to harmonise approaches in biotechnology and new technologies in agriculture. In January 2016, Australia released a joint statement with Argentina, Brazil, Canada, Paraguay and the Unites States advocating removal of global barriers to the trade of agricultural biotechnology and promotion of science-based regulatory approaches.

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