Gene technology regulations Part 1. Current treatment of new breeding technologies by the existing Gene Technology Regulations in Australia

David Tribe.

(Based on Australian Gene Technology Regulations 2001 F2019L00573 20 October 2020).

The current treatment of new breeding technologies, such as gene editing, under the existing Gene Technology Act 2000 and Gene Technology Regulations 2001 in Australia provides a nuanced approach towards distinguishing between organisms modified through gene technology (genetically modified organisms, or GMOs) and those that aren't.

Under the current legislation, the use of gene editing technology can fall under either the definition of gene technology or not, depending on the specifics of the technique employed.

Key Definitions from the Act:

The Act defines gene technology as any technique for the modification of genes or other genetic material, excluding sexual reproduction, homologous recombination, or any other technique specified in the regulations.

A genetically modified organism, as per the Act, is an organism that has been modified by gene technology, or has inherited particular traits from an organism because of gene technology, or anything declared by the regulations to be a GMO. This does not include a human being that has undergone somatic cell gene therapy or an organism declared by the regulations not to be a GMO.

Relevance to Gene Editing and New Breeding Technologies:

The way that gene editing is treated under the current regulations largely hinges on Schedules 1A, 1B, and 1 of the regulations. These schedules clarify which techniques and resulting organisms are or aren't considered as involving gene technology.

• Schedule 1B, Item 2: 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 added to guide homology-directed repair, is still considered a product of gene technology.
• Schedule 1, Item 4: An organism that has been 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, is not considered a GMO.

This suggests that gene editing can be classified as either (i) gene technology or (ii) not gene technology based on whether a nucleic acid template was used to guide the repair process. If a guide template is used, the organism is considered a GMO. If no guide template is used, the organism isn't considered a GMO, as the change might have occurred naturally or through traditional mutagenesis methods that have a long history of safe use.

Considerations for Innovators

Gene Editing Flexibility under Australian Gene Technology Regulations

1. Technique Matters: The type of gene-editing technique used is crucial in determining if the organism will be considered a GMO.
2. Use of Guide Templates: Using a nucleic acid template to guide DNA repair during gene editing means the organism is a GMO. Not using templates can keep the organism outside of the GMO classification.
3. Analogy to Traditional Mutagenesis: Techniques that mimic the damage caused by traditional mutagenesis methods aren't considered gene technology.
4. Regulatory Scope: Clear comprehension of the regulatory guidelines can prevent legal complications.
5. Dynamic Landscape: The rapidly evolving field of biotechnology and the legislation surrounding it demand regular updates on the latest regulatory changes.

 

Information resources:

National Gene Technology Scheme (webpage).

The National Gene Technology Scheme is a collaboration between all Australian governments, supporting a nationally consistent regulatory system for gene technology in Australia.

National Gene Technology Scheme 2017 – Third review (webpage)

The third review of the National Gene Technology Scheme considered technical, regulatory, governance and social and ethical issues. It also looked at modernising and future proofing the scheme.

Gene Technology Regulations 2001 F2020C00957  20 October 2020

Gene Technology Act 2000 C2016C00792 13 July 2016

Later posts in this series

Gene technology regulations Part 2.How to start doing risk management: OGTR 2013 Risk Analysis Framework Overview: Attention to Context

Gene technology regulations Part 3: Enhanced International Standards Bolster Biotechnology Risk Management