Gene editing

The real-world applications of gene editing are no longer theoretical. For example:

• In human health, these tools are being used in an increasing number of clinical trials, including a trial that began in Aotearoa in July, where it is hoped that a one-off CRISPR treatment will provide a new way to support individuals with hypercholesterolaemia to control their LDL cholesterol levels.
• Agricultural applications are widespread, including the development of disease-resistant plants and animals and produce with modified properties – like GABA-enriched tomatoes that can be purchased Japan and soybean oil that’s free from trans-fat in the US. Gene editing can be part of the response to climate change. For example, it offers a way to develop crops that are more heat tolerant or able to withstand droughts and other extreme weather events, which are becoming increasingly common.
• Gene drives, a specific application of CRISPR which leads to selected genes spreading through a population more rapidly than by chance alone, have applications in pest management and the control of vector-borne disease. Again, this technology has moved beyond the lab, with a biotech company using gene drives to control mosquito population sizes in multiple countries.

Previous analysis of the gene editing landscape in Aotearoa

In 2016, the Royal Society Te Apārangi published an evidence update outlining the science and history of gene editing, new techniques, and possible applications. In 2019, the Royal Society Te Apārangi developed a series of gene editing scenarios in healthcare, pest control, and the primary industries, which it used to explore scientific, ethical, social, and legal questions associated with gene editing and its applications. The subsequent report on gene editing included a section on New Zealand’s regulatory framework, arguing that Aotearoa to develop its own perspective on gene editing, informed by public engagement, and should ensure our regulatory frameworks are fit for purpose.

In a briefing to the Prime Minister in 2019 in response to the Royal Society Te Apārangi report, the Prime Minister’s Chief Science Advisor agreed that Aotearoa New Zealand lacks a clear regulatory and legal framework on gene editing, and that current frameworks need modernising. She also endorsed the panel’s observation that the gene editing debate requires widespread public engagement. In particular, she noted the importance of substantive engagement with Māori. In 2023, Juliet provided an updated briefing letter to the Prime Minster. It reiterated her agreement with the widely held view that our current legal and regulatory frameworks are not appropriate for the genetic tools available in 2023.

In response to the Royal Society Te Apārangi report, Environment Minister Hon David Parker asked his officials to advise him “of where lower regulatory hurdles ought to be considered to enable medical uses that would result in no inheritable traits, or laboratory tests where any risk is mitigated by containment,” and noted that “the recommendation to clarify conflicting or inconsistent definitions across the regulatory framework will also be considered.”

The Climate Change Commission’s 2021 report[1] advising the government on emissions budgets included these two comments:

         44 Several submissions proposed genetic engineering (GE) as an approach to reducing emissions, while others were very wary about the market and environmental consequences of using GE in Aotearoa. Some submissions discussed the need for more evidence of effectiveness in farming systems in Aotearoa.

         45 The regulatory environment must not hinder the roll-out of effective new emissions-reducing technologies and practices.

The Productivity Commission’s report[2] on ‘frontier firms’ in New Zealand included these two comments:

• Modern genetic modification (GM) technologies such as gene-editing offer potential new opportunities for boosting productivity, improving health outcomes, reducing biosecurity risks, and responding to climate-change risks and other environmental problems effectively and efficiently.
• The regulatory framework for GM tools was last reviewed in 2001 and does not reflect technological advances since that time. The Government should review the GM regulatory framework, to ensure it is fit for purpose. This review should include wide engagement with industry, iwi and Māori interests, and the general public.

The WELL_NZ report on GM is a reference document from Te Puna Whakaaronui, the joint Government and industry food and fibre sector think tank, on modern genetic technologies and their regulation in NZ. The stated goal of the document was “to provide an unbiased, fact-based resource for those seeking to better understand the current state of genetic technology and associated regulations around the world”.

In 2019 Maui Hudson and colleagues published a research article, Indigenous perspectives on gene editing in Aotearoa New Zealand, that examined how Māori viewed the potential impact of gene editing in the context of their world view. They note that “The outcomes of this pilot study identified that while Māori informants were not categorically opposed to new and emerging gene editing technologies a priori, they suggest a dynamic approach to regulation is required where specific uses or types of uses are approved on a case by case basis.”

The Aotearoa Circle reported in 2024 on modern genetic technology in NZ agricultural production systems. “The primary objective of this report is to enhance comprehension regarding the potential environmental impacts of genetic technology and the trade-offs associated with various regulatory approaches”.

In 2024 the Biological Heritage National Science Challenge reported on research titled “Genetic Technologies and Our Environment”. This examined the public and Māori perceptions of gene technologies used in the natural environment using deliberative processes. One key finding was that “Fundamentally, New Zealanders saw the possible introduction of gene technology into the environmental management architecture to be less about the technologies themselves, and more about the social, economic and environmental factors.”

Timeline of events

• Thousands of years ago – Selective breeding used to increase the prevalence of plants and animals with desirable characteristics, especially in agriculture.
• 1930s – Chemical techniques and ionising radiation start to be used to accelerate the rate of genetic change.
• 1970s and 1980s – Genetic engineering techniques developed that enable genetic material to be inserted into genomes, but often with limited precision.
• 1996 – HSNO Act introduced in New Zealand, where a genetically modified organism is defined as any organism in which the genes or genetic material have been modified by in vitro techniques, or a related organism.
• 1998 – Regulations under the HSNO Act specify that organisms resulting from the use of chemical or radiation treatments in use before 1998 are not genetically modified.
• 2001 – Royal Commission on genetic modification finds that the basic institutional structures and regulatory framework for dealing with genetic modification technologies is appropriate, needing only ‘fine tuning,’ which takes place in 2003.
• 2005-2012 – Three main precision gene editing tools developed (ZFNs in 2005, TALENs in 2010, and CRISPR in 2012).
• 2014 – Sustainability Council vs EPA case in the High Court which finds that plants created using gene editing tools like ZFN-s and TALEs are new organisms as defined by the HSNO Act, along with older technologies such as chemical and radiation mutagenesis previously thought exempt from regulation.​
• 2015/20162016 – Ministry for the Environment (MfE) produces a regulatory impact statement in the wake of the high court decision. The Organisms not Genetically Modified Regulations (1998) are updated in 2016 to add a cutoff date of July 1998 for existing technologies to result in organisms not considered to be genetically modified.
• 2016 – Royal Society Te Apārangi publishes gene editing evidence update, detailing the emergence of gene editing tools and their increasing use in research and practice.
• 2019 – Royal Society Te Apārangi publishes report on gene editing scenarios and regulations; the report notes that the NZ regulatory system is not keeping pace with the advances in biotechnology.
• 2019 – PMCSA provides a briefing to the Prime Minister on the Royal Society Te Apārangi report, agreeing that Aotearoa lacks a clear regulatory and legal framework on gene editing, and that current frameworks need modernising.
• 2019 – Minister Parker asks officials to advise him of where “lower regulatory hurdles ought to be considered to enable medical uses that would result in no heritable traits, or laboratory tests where any risks are mitigated by containment”.
• 2021 – Climate Change Commission provides advice to government on its first three emissions budgets, including the observation that “several submissions proposed genetic engineering (GE) as an approach to reducing emissions, while others were very wary about the market and environmental consequences of using GE in Aotearoa.”
• 2021 – Productivity Commission calls for the regulatory settings governing genetic modification to be reviewed, to reflect advances in gene technology and enable New Zealanders to access opportunities for “boosting productivity, improving health outcomes, reducing biosecurity risks, and responding to climate-change risks and other environmental problems effectively and efficiently.”
• 2023 – PMCSA provides a letter to the Prime Minister updating her 2019 briefing and reiterating the need for a clear regulatory and legal framework on gene editing, and modernisation of the current frameworks for regulating genetically modified organisms.
• 2023 – Ministry for the Environment consults on proposed changes to New Zealand’s legislation and regulations for genetically modified organisms used in laboratory settings and for biomedical therapies.
• 2024 – The NZ EPA releases a clarification that the progeny of GMOs that do not inherit the transgene are not regulated as genetically modified organisms under the HSNO Act.
• 2024 – NZ Government announces it will create a new dedicated gene technology regulator hosted within the EPA.  Select committee hearings on the legislation are expected in Q1 of 2025.

Regulation in some example jurisdictions with relevance to NZ exports

Glossary of gene editing terms

Traditional/conventional breeding: a technique where two organisms are crossed to produce offspring for commercial (or other) reasons. Includes:

• Selective breeding: a breeding technique where the parents and/or offspring are selected specifically for their known genetic characteristics.

Mutagenesis: a technique where the DNA of an organism is permanently altered by the application of a chemical or physical agent (such as radioactivity or UV radiation).

Genetic modification (GM) / genetic engineering (GE): techniques where the DNA of an organism is altered by scientists through the permanent addition of DNA from another source. Includes:

• Transgenic: modifying an organism with DNA from another species.
• Cis-genic: modifying an organism with DNA from its own species.

Null segregant: offspring of a genetically modified organism that does not carry the modified and/or foreign DNA.

New breeding techniques (NBTs) / precision breeding: techniques where the DNA of an organism is altered by scientists in a targeted and precise way. Classified as genetic modification under New Zealand regulations. Includes:

• Gene editing / genome editing: a technique where a change to the DNA of an organism is triggered at a very specific point in the DNA by causing a cut in the DNA. The most common technology is known as CRISPR-Cas9.
• In some regions (including Australia), products of gene editing are classified as:
  • SDN-1, where a small change DNA occurs at a targeted point in the genome, with no external DNA inserted.
  • SDN-2, where an existing gene is replaced with a new gene with a similar DNA sequence (for example, from the same or related species) and the new template DNA is physically inserted at the targeted point.
  • SDN-3, a new gene (from any species) is added at a targeted point in the genome and the new DNA is physically inserted.
• Newer techniques fall outside these categories as they do not (completely) cut the DNA
  • Base editing: a technique that where a change to the DNA sequence of an organism is targeted at a single targeted point, without the permanent addition of DNA from another source.
  • Prime editing: a technique where a targeted point in the DNA sequence is rewritten using a temporary primer/template, without the permanent insertion of DNA from another source.

Negative events where GM plants or animals were involved

In an examination of media reports and other literature I was able to identify a number of instances where experimentation using genetically modified organisms was not carried out to the agreed standard, including here in NZ. See this report, and this report. Remedial actions were taken, and in all but one case the organism did not persist in the environment. In one case in the USA the organism (creeping bentgrass) has become established in agricultural environment (drainage ditches) but does not appear to have spread further. There have been a number a media reports about GM trials in NZ (here, here and here) but these do not indicate that failures in containment as required by law were permitted to occur, but rather the groups opposed to the use of GM were actively campaigning against the trials. Internationally, following release into production and sale there are a small number of cases where the organism has spread beyond its intended locations (See here, here and here). Finally, there is the rather unusual case of the orange petunia. Apparently made in Europe before being stolen and incorporated into worldwide breeding programs a transgenic petunia was sold around the world and in NZ before being detected and recalled.

Read more

• Victoria University of Wellington Law Review paper on legal considerations of gene editing, (01 October 2019).
• Frontiers in Bioengineering and Biotechnology paper on te ao Māori views on genetic technologies, (11 April 2019).
• Human genome editing recommendations from a WHO-convened expert committee (12 July 2021) which is summarised and contextualised in this Nature article (12 July 2021).
• Detailed report from UN FAO on the potential of using gene editing to address issues in agricultural systems (2022).
• List of biotechnology regulators worldwide, compiled by Biosafety Clearing House as part of managing the movement of genetically modified organism between countries.

Media content

• A TED talk on gene editing by Jennifer Doudna, who was jointly awarded the Nobel prize for Chemistry along with Emmanuelle Charpentier.
• Gene editing explained at 5 expertise levels by Neville Sanjana.
• From cancer-killing cells to fake burgers – is NZ ready for genetic modification? an NZHerald article (paywalled) which includes an interview with Juliet (17 October 2022).
• Report on GM and gene editing in the laboratory Newshub including David Parker (Environment Minister).
• National Party biotech policy news release.
• An RNZ Nights interview with OPMCSA fellow Revel Drummond; a wide ranging discussion on GM and gene editing.

[1] see Section 17.1.4 page 308

[2] see Section 10.4 page 162

Last edited: 16 August 2024