Gene tech rule changes in New Zealand – Expert Reaction

Date:08-14-2024

The Government is moving forward on its intentions to overhaul restrictions on the use of gene editing and other genetic technologies in New Zealand and establish a dedicated regulator.

Legislation is expected to go to Parliament by the end of the year, removing regulatory hurdles on developing genetic technology beyond the lab that have been in place for the last 30 years.

The announcement says the new legislation will be based on Australia’s Gene Technology Act 2000 and modified to work here in New Zealand. The ‘new’ regulator will be set up as a dedicated business unit within the Environmental Protection Authority (EPA).

The SMC asked experts to comment.

Dr Richard Newcomb, Chief Scientist, Plant & Food Research, comments:

″Aotearoa New Zealand generates a lot of wealth by sustainably growing healthy kai which we share with consumers around the world. These new regulations will allow scientists to develop new plant varieties so the agrifood sector can adapt at the speed required to meet fast-moving challenges, such as climate change, and remain competitive on the global market.

″Regulations around gene technologies, particularly with the advent of high precision technologies such as CRISPR-Cas9, are changing around the world. Researchers and food producers overseas are using these new technologies to develop foods that will directly compete with those from Aotearoa, and may have more of the characteristics that consumers want.

″By changing our regulations, our sectors can compete on a level playing field; with a wider range of technologies on the table, they will be better placed to be able to make choices that are good for Aotearoa as well as the world.″

No conflicts of interest.

Richard Scott, Science Team Leader, AgResearch, comments:

″The moves announced today by the Government are welcome after decades of inaction on regulations for genetic modification and gene editing. Much of the rest of the world has already made changes, or is in the process of making changes, to accommodate gene technologies that are now more precise and safer than they have ever been. In some cases, these technologies have been safely used overseas for decades now.

″The approach proposed for New Zealand, which excludes ‘low-risk and well-understood gene technologies’ from regulation, is sensible. We know that certain changes made by gene editing, for example, are virtually indistinguishable from changes that can occur naturally or through conventional breeding of organisms. We support an evidence-based regulatory approach to the risks of any given solution or product, as opposed to focusing on the methods used to produce them.

″The health of people and the environment must remain central to any changes, which the Government has recognised, with the intention to establish a gene technology regulator similar to Australia’s Office of the Gene Technology Regulator. It is essential that a well-designed and equipped regulator is in place to ensure that any genetically modified or gene edited organisms, or products derived from these processes, are safe and deliver what is intended upon release. It is also critical that New Zealanders have confidence that any proposed changes that might affect their environment or food supply are subject to the appropriate level of scrutiny, and that communities feel heard on these issues.

″Among the solutions being worked on in New Zealand are pastures enhanced through use of gene technologies to increase farm productivity, improve livestock health and reduce the environmental impact of agriculture – for example, research on modified white clover that feeds livestock. A lot of these solutions take many years to trial, test and refine, and we don’t expect a flood of new products to be proposed for release in New Zealand in the early stages of a new regulator.

″It is encouraging, however, to hear that an initial list of non-regulated activities will be communicated to provide certainty to researchers, so that we can plan and the work can get potentially get underway as soon as the new legislation and regulations come into force. We look forward to hearing more about what this regulator will look like and the continued involvement of our researchers – who have extensive experience and expertise in gene technologies – in providing advice and working with the regulator.

″While there has been a national conversation building in recent years on use of these gene technologies, the introduction of new laws and regulations is likely to bring it to the attention of a wider group of New Zealanders who have not necessarily paid attention to the topic previously. It is important that these people have access to trusted information, so they feel informed on these issues. That is where organisations like AgResearch also have a role to play.″

Conflict of interest statement: ″I work on gene editing and genetic modification research for AgResearch, alongside commercial partners.″

Professor Michael Bunce, Genetics Expert and Honorary/Adjunct Professor at the University of Otago and Curtin University, comments:

″Since rules surrounding the use of gene technologies were established in 1996 (the HSNO act) the face of genetics has changed drastically. It is therefore appropriate that legislation and regulation is also being changed.

″To provide some perspective, in 1996 the human genome project was underway at a cost of $4 billion that took a decade to complete. The same genome today costs $1000 to map taking about a day. Across Aotearoa in the past couple of years we have seen genetic technologies being used to detect Covid-19 and other diseases, develop vaccines, detect biosecurity incursions and innovate cancer therapies.

″As our understanding of genomes increases and new precision genome editing tools (such as CRISPR-Cas9) come online it follows that new rules and regulations need to keep pace and remain agile. The 1996 HSNO Act is currently out of step internationally and can’t adapt to new innovations. We are seeing gene edits that are indistinguishable from traditional breeding approaches – new legislation needs to be able to deal with this precision editing.

″Asking if gene editing is ‘good or bad’ is like asking if the internet is ‘good or bad’. We need to step past this binary state. It requires us to zoom in on a given application to make the ‘call’ as to what benefits society, environment and the economy, and what might be damaging or an unacceptable risk.

″This is a technical and nuanced conversation for New Zealand to have. It requires us to pick up our DNA ‘game’ a little, and park debates from last century when gene technologies were still in their infancy. We may also have to accept that the country may remain divided on this topic – some New Zealanders will remain opposed to gene editing.

″Similar to Australia, the proposed changes seek to set up dedicated regulatory function that implements the intent of the proposed Gene Technology Bill. The decision has been made to place this within Environmental Protection Authority (EPA) is important as it means risk-based decisions will be made free from political influence.

″We are yet to see details, but I hope that, despite fiscal constraints, that the EPA is provided with resources to successfully navigate complex technical, cultural and ethical issues.

″As it is presented these reforms don’t signal a ‘free-for-all’ surrounding gene editing, far from it. Rather it means – for some activities – barriers are reduced and the work is placed within a tiered risk framework. Examples of low-risk activities include experiments in laboratory containment, and for the use of cancer therapies such as CAR-T cells that are confined to the patient.

″At the other end of the spectrum if environmental release is sought there may still need to be a thorough consultation. But even within ‘environmental release’ there are different risk profiles. For example, sterile pine trees are not able to spread into the environment whereas a closer look at other plants still capable of reproduction might be warranted. It all depends on the context.″

No conflict of interest.

Note: Prof Mike Bunce is a geneticist and an honorary/adjunct professor at Otago and Curtin Universities. He was formerly Chief Scientist at the EPA that currently regulates genetic technology in NZ. In his former role as Chief Science Advisor at DOC (which ended in June 2024) he sat on an interdepartmental steering group on gene technology reforms.

Professor Jack Heinemann, Professor of Genetics, University of Canterbury, comments:

″There is no ban on gene technology in New Zealand. This misleading hyperbole is used to obscure a failure to engineer products that will have a market or social value that exceeds the cost of compliance with reasonable regulations.

″According to MPI, New Zealand’s agriculture exports are worth $54 billion, and 10.5% of our gross domestic product. The entire enterprise is what our biotechnology can do. This value was achieved by solid science and hard work. It has benefitted from molecular biology, but it is not dependent on producing genetically modified organisms.

″Presently, there are only claims that genetic modification will produce the benefits that the Government is convinced are only a mutation away. This has been the claim since the 1970s. Government looks to countries that have released GM plants, and says that is because their regulatory regimes are more permissive. Is this the explanation, or is the explanation that those countries grow large monocultures that are sustained by herbicide resistant crops and herbicides, a model that might not work for the more textured cropping of New Zealand? The Government also doesn’t say that most of those countries have almost no agriculture based on GM plants, and amongst the remainders it is still a minority of their crop production but a majority of a few staple crops.

″Sure, the more gene technology is used the more plants, animals, fungi, and bacteria will be genetically modified. That does not mean that they will be organisms that will be climate resilient, higher yielding, or more nutritious through genetic engineering. Indeed, even framing genetic engineering as the solution to these problems shifts our attention away from what causes these problems, and therefore shifts our efforts away from sustainable solutions.

″There is no robust evidence that New Zealand’s regulation have prevented, or will prevent, truly useful products from coming to market. Products with estimated market value less than the small costs of compliance are not going to save the world because they are either not intended to, or because they will not be capable of doing so. The majority of what will be commercialised under less rigorous regulations are novelty items or will exacerbate agriculture practices that grow environmental harm and climate change. The best that can be said, as the cartoon goes, is that they destroy the world less quickly.

″Regulations that impede responsible use of gene technology in medicine and health care are a different matter. There is evidence that other relevant regulations can be redundant with gene technology regulations. That isn’t so for agriculture and environmental releases.

″Gene technology de-regulation de-powers the people. It doesn’t empower real change.″

Conflict of interest statement: ″Expert witness for councils on GMO provisions and High Court on determination of genome editing as a process that creates GMOs, former member of the Ad Hoc Technical Expert Group on Risk Assessment and Risk Management of the Conventional on Biological Diversity, author IPCC 6th Report.″

Associate Professor Josephine Johnston, Bioethics Centre, University of Otago, comments:

″It is not a surprise to see new law and a new regulatory approach proposed for this area—that was signalled during the election but it has also been fairly widely called for over the past six or seven years.

″It’s not a surprise that the approach we adopted in 1996 needs a big refresh. There’s not a lot of detail in what was announced today but the overall message is that greater use of genetic technology will be permitted, whether in medicine, agriculture or the environment. It will matter a great deal how the new regulator approaches, assesses, and manages risk and we don’t know much about that yet.

″I think it’s a good idea to model a new approach on one from overseas—we don’t always need to reinvent the wheel and Australia has had their regulator in place for over 20 years. That said, it will be important to adapt that approach in light of our country’s special features, and there I immediately think of our Treaty commitments and the high value we place on our natural environment. Some of these technologies might be able to actually help with conservation—but we have very good reasons to be especially cautious when it comes to our natural environment, which is a lesson we learned the hard way after introducing pests that we now struggle to remove. So I think New Zealand needs to tailor this regulatory approach to prioritise our needs and values, including Te Tiriti commitments and particular care for our environment.

″In the area of medicine, there certainly are exciting developments and we will want access to them, so clearing a path is important.

″Overall, I hope this is not a highly politicised discussion, but New Zealanders will need a minute to catch up to a whole new approach to gene technology and I hope there is space for public engagement and learning together.″

Conflict of interest statement: ″In addition to my employment, I am co-chair of the Health Research Council of New Zealand’s Ethics Committee and a member of the Gene Technology Advisory Committee. I have been funded by HRC and National Institutes of Health in the US to research issues in ethics and genetics, but I have not been funded by industry.″

Note: Associate Professor Johnston is also a Senior Research Scholar at The Hastings Center, a bioethics research institute in New York.

Dr Zahra Champion, Executive Director, BioTechNZ, comments:

″I welcome today’s announcement by Hon. Judith Collins, Minister of Science, Innovation and Technology,

″Current regulations for genetic technologies are outdated and not fit for purpose. For years they have been hampering companies and researchers from keeping pace with scientific advancements and have been stifling innovation.

″This decision reflects the government’s commitment to enabling New Zealanders to responsibly and safely open up access to the benefits of gene technology, which is crucial for addressing critical challenges in agriculture, healthcare, and environmental sustainability.″

No conflict of interest.

Dr Alec Foster, Portfolio Lead Bioproducts – Scion, comments:

″I applaud the gene technology reforms announced today by the Government for their potential to advance research and create a cleaner, greener, and more prosperous New Zealand.

″New Zealand can no longer afford to shy away from the transformative potential of cutting-edge genetic technologies. The proposed legislation, which mirrors Australia’s Gene Technology act, allows for greater use of gene technologies and removes unnecessary barriers to research that has long been stifled. This opens up a wide array of opportunities that are key to achieving important environmental and societal goals while also improving productivity.

″Gene technologies have evolved rapidly, and in recent years, New Zealand has been left behind. Today’s announcement represents a step change in New Zealand’s ability to tackle many challenges where biotechnology is a key tool for resolution. I anticipate that this legislation will also support our industries in delivering new high-value products and becoming more competitive on the international stage.

″New gene editing techniques, like CRISPR, offer a precise and efficient way to develop crops and livestock with desirable traits. These methodologies accelerate and refine natural breeding processes, achieving results with unprecedented accuracy and speed. These new breeding technologies are at the heart of today’s announcement and are set to revolutionise our primary industries. Beyond agriculture, the reforms promise significant advancements in healthcare, paving the way for innovative medicines and therapies. Additionally, industrial biotechnology stands to benefit greatly, with potential breakthroughs in the production of chemicals, fuels, and enzymes that are vital to multiple sectors of our economy.

″Through favorable biotech regulations, other countries are already well ahead of us. By 2040, Australia’s national science agency, CSIRO, projects a $30 billion benefit and 50,000 new jobs from using gene technologies. The United States is investing billions and aims to replace 30% of chemicals and 90% of plastics with biotechnology-derived alternatives by leveraging genetic engineering and bioengineering tools, using various biomass streams as feedstock. Even the European Union, long cautious about genetically modified crops, has followed the UK and recently voted to ease regulations to maintain crop yields, reduce chemical inputs, and bolster food security amid climate change.

″In New Zealand to date, gene technologies have been used, but restrictive rules and time-consuming processes that have stifled research as well as innovation outside the laboratory. The decision to update New Zealand’s gene technology mirroring Australia’s Gene Technology Act is very positive. There is also an opportunity for New Zealand to further improve upon this framework. One of the most promising areas is in Industrial Biotechnology. The apparent provision for utilisation in contained facilities, such as fermenters used in precision fermentation and industrial biotechnology, is particularly encouraging. This opens up immediate opportunities for New Zealand in this field, potentially positioning us at an advantaged position given our ability to produce biomass/feedstocks for fermentation.

″Scion is at the forefront of pioneering research in forestry gene technologies, and it is anticipated that this work will benefit significantly from the legislation change. One of our key projects involves developing sterile pine trees incapable of sexual reproduction, addressing the long-standing issue of wilding pines invading and degrading our natural ecosystems. This innovative approach could allow us to reap the economic benefits of plantation forestry while significantly mitigating its environmental risks. Another crucial project at Scion explores enhancing carbon capture in trees, a vital tool in our fight against climate change. By modifying genes that control growth rates and biomass accumulation, we aim to develop trees capable of sequestering substantially more carbon dioxide from the atmosphere.

″Beyond plant-based applications, our research extends to microbial biotechnology. We are advancing technologies that harness carbon dioxide and methane, along with dairy waste streams, converting these inputs into valuable products through bacterial fermentation. This process yields sustainable alternatives such as animal feed, chemicals, and bioplastics, exemplifying our commitment to circular economy principles. The proposed legislation is expected to provide a crucial framework for realising the full potential of this research.

″In the three decades since New Zealand last engaged in a national dialogue on genetic engineering, the field has undergone a remarkable transformation. Today, we stand with a wealth of evidence and real-world applications that underscore the transformative impact of genetic technologies. These advancements promise to revolutionise our economy, enhance environmental stewardship, and improve the health outcomes for New Zealanders. Moreover, the safety of these technologies has been rigorously validated through thousands of studies and the successful deployment of numerous products worldwide.″

Conflict of interest statement: Executive Committee Member BiotechNZ, Part of Technical Advisory Group for Genetic Technologies for MBIE

Dr Nikki Freed, Chief Scientific Officer, Daisy Lab, comments:

″Daisy Lab welcomes these proposed regulatory changes. We believe they will reduce red tape and accelerate New Zealand’s ability to respond to climate change. These changes also create opportunities to strengthen our biotechnology and bioprocessing sectors, with a focus on exporting high-value ingredients such as enzymes and nutraceuticals. Additionally, the changes could lead to significant improvements in the health of New Zealanders through innovative cancer therapies. These changes will help align New Zealand’s regulations on genetic modifications with global standards. Regardless of the outcome, Daisy Lab remains committed to operating within the current regulations.″

Conflict of interest statement: ″I am also on MBIE’s Gene Technology Regulator Technical Advisory Group (TAG). I sit on the TAG as a scientist doing research in both the academic (University of Auckland) and industrial space (Daisy Lab).″