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Regulating genetic technologies in Aotearoa – Expert Q&A

The Government plans to overhaul restrictions on the use of gene editing and other genetic technologies in New Zealand, and establish a dedicated regulator within MBIE.

Two Prime Ministers Chief Science AdvisorsScience New ZealandPlant & Food Research, and a gene editing expert panel convened by the Royal Society Te Apārangi, have all previously supported an update to the current system.

The SMC asked experts to outline the current state of genetic technology regulation in Aotearoa, and what could change under National’s ‘Harnessing Biotech Plan’

Dr Revel Drummond, Scientist, Plant & Food Research Ltd, comments:

  • What implications would the shift to a new biotechnology regulator have for the legal and policy landscape around genetic technologies in NZ?

“Currently, genetic technologies are regulated through multiple pieces of legislation across different authorities – including the EPA , MPI, Medsafe, Standards NZ, FSANZ and more. A new regulator could act as a centralised ‘first point of contact’ for genetic technologies with appropriate focus on the opportunities and risks associated with these technologies.

“The law could be simplified, made consistent, and updated to:

  • reflect current scientific understanding.
  • reflect current scientific practice, but also be forward looking and flexible
  • better align with the laws of our major trading partners.
  • better reflect current citizen and consumer attitudes.

“New Zealand could be world leading by learning from the many other regulatory systems that have already been updated to reflect current scientific practice.

“The current system is severely inhibitory to the development of a biotechnology sector in New Zealand. A strong and trusted regulator is key to managing biotechnology in NZ and it being accepted as an important part of our lives and economy. Internal and external review and modification to rules could be codified in the law to enable swift adaptation to new information.”

  • How would this compare with frameworks in other countries?

“Australia has a centralised ‘first point of contact’ in the form of the Office of the Gene Technology Regulator. The new law could explicitly build in concepts of regulation proportionate to risk, which many other countries have in one form or another.”

  • What, in your view, would be the most significant change that a new biotechnology regulator could make? 

“A new biotechnology regulator could ensure regulation is proportionate to risk, and create a tiered structure of regulation built on scientific, cultural and economic risk profiles. We might also see a flexibility of rules that is inherently agnostic to the method of DNA modification and focused instead on the intended and actual outcome. We might also see the separation of ‘new organisms’ regulation from ‘genetically modified organism’ regulation.”

Conflict of interest: Dr Revel Drummond is investigating the potential of gene technologies in a New Zealand context.

Dr John Caradus, CEO, Grasslanz Technology Ltd, comments: 

  • How does New Zealand’s current regulatory system for genetic technologies compare with our international counterparts?

“While genetic modification has continued to be used as a research tool and for medical purposes when shown to be safe and beneficial, it has gained no traction in improving New Zealand’s economic wellbeing. The option to ‘go forward but with care’ as espoused by The Royal Commission on Genetic Modification nearly 25 years ago, has in conjunction with the HSNO Act stopped attempts to bring genetic modification technologies out of containment, so that demonstrated benefits in controlled environments can be extended to real world field trials.

“While a cautious approach to regulating GM crops may have been justified in the early years of GM crop commercialisation, in the interim 25 years with an expanding knowledge of plant genomics it is now understood that ‘the genetic engineering process itself presents little potential for unexpected consequences that would not be identified or eliminated in the variety development process before commercialisation’.

“Regulatory frameworks should be product rather than process based, as they are in New Zealand, so that it is the novelty of the characteristics of new plant cultivars that are being regulated.

“The Precautionary Principle, which underpins the HSNO Act regulations, is based on the maxim of ‘better safe than sorry’ and has been defined as ‘imposing early preventive measures to ward off even those risks for which we have little or no basis on which to predict the future probability of harm’. Unfortunately, some have assumed that precaution means prevention.

“An uncompromising approach to the Precautionary Principle would inevitably result in no action ever being taken, because an assurance of absolute safety can never be given, leading to paralysis and a cessation of technological advancement.

“New Zealand is increasingly becoming an outlier on regulation of genetic modification and gene editing technologies, and on the question of impact it would be great be able to test technologies such as the High Metabolisable Energy ryegrass and high condensed tannin white clover in outdoor settings in NZ pastures to see what they can deliver for farmers and NZ.

“New Zealand’s approach to regulating genetic modification techniques under the Hazardous Substances and New Organisms Act 1996 was last reviewed in 2001 and does not reflect technological advances since that time. It boldly recommended that the Government should undertake a full review of the regulation of genetic modification, to ensure it is fit for purpose and supports domestic innovation. That is yet to happen.”

  • What impact could new legislation and a new biotechnology regulator have on the agricultural sector?

“New Zealand is one of few developed countries that has a regulatory system that is unable to differentiate between genetic modification and gene editing using targeted mutation and with no introduction of foreign DNA.

“The European Union has had a similar approach but even here recent developments have proposed that plants developed using New Breeding Techniques (which include gene editing) be considered equivalent to conventional ones that would be exempted from the requirements of the GMO legislation. The driver for this change has been to make the food system more sustainable and resilient by developing improved plant varieties that are climate resilient, pest resistant, and give higher yields or require fewer fertilisers and pesticides. Food production is facing many challenges worldwide. There is a growing population to feed and at the same time pressure to reduce environmental impacts such as greenhouse gas emissions that contribute to climate change.

“Tools such as genetic modification and gene editing may offer some solutions to help farmers and food producers reduce their environmental footprint while remaining productive and profitable. This is why research is being undertaken to see what is possible and what the benefits and risks are. In a New Zealand context, we also need to know that these solutions will work for farmers and growers in our unique conditions.

“Indeed, it is propositioned that genetically modified cultivars are safer than those bred using traditional methods without the use of genetic modification because they are made in a very precise manner. Technological progress is inevitable and with that a responsibility to evaluate the risks but from the perspective of seeking decisions based on fact, as currently understood, using scientific (not philosophic) knowledge.”

Conflict of interest: John Caradus is employed by Grasslanz Technology Ltd which has an R&D investment portfolio that includes both genetic modification and gene editing of forages and microbes to provide mitigating solutions to current environmental and animal welfare issues facing both New Zealand and other pastoral economies.

Dr Alec Foster, Portfolio Leader – Bioproducts and Packaging, Scion, comments: 

  • What are the implications of a shift to a new biotechnology regulator within the microbiology space?

“Of all the potential applications of genetic modification, those associated with microorganisms are likely to have the greatest immediate impact in New Zealand. Genetically modified microorganisms are already widely used globally to produce enzymes, medicines, chemicals, and food products. Contained use of genetically modified microorganisms is a common and well-established practice worldwide.

“Reflecting their long history of safe use in fermentation/manufacturing and different risk profiles, genetically modified microorganisms are often subject to different, less stringent regulations to other GMOs.

“However, New Zealand’s rigid regulatory framework has stifled innovation in both research and commercialisation domestically. This regulatory burden has been cited by notable biotech companies, like LanzaTech, as a primary reason for moving offshore. Modernising the regulations would enable agile exploration of novel opportunities and enable New Zealand to fully capitalise on emerging small and medium enterprises working in this high-value sector.

“Updating New Zealand’s outdated approach to genetically modified microorganisms would allow the country to pursue new strategies to tackle its economic and environmental goals. Genetically modified microorganisms could enable the biomanufacturing of sustainable alternatives to animal proteins and agricultural chemicals. They could also facilitate the production of pharmaceutical ingredients, precursors, and compounds traditionally derived through plant extraction or fossil fuel-based chemical synthesis. Genetically modified microorganisms could provide biological solutions for biomass utilisation and recycling, as well as the biomanufacturing of more sustainable chemical materials and fuels.

“With prudent, tailored regulations, microbial biotechnology in New Zealand could foster innovations in primary industries, medicine, manufacturing and energy. Microorganisms present opportunities to develop new products and processes with lower environmental impacts and are generally considered a fundamental element of transitioning to a circular bioeconomy.”

Conflict of interest: Dr Alec Foster is an Executive member of BioTechNZ.