STEWARDING: BIOTECHNOLOGY

New Zealand ‘does not pay sufficient attention to the future or guard against risks that can be readily foreseen.’ (Palmer and Butler 2018)

EXCERPT FROM THE 2023 PAPER: Deregulation? Biotechnology & gene editing: New Zealand context. PDF

INTRODUCTION

This 2023 report summarises key issues relating to science, stewardship and risk of biotechnologies in New Zealand.

In Aotearoa New Zealand there are gaps and barriers to effective stewardship, science and regulation regarding biotechnology. This includes the regulation of newer technologies such as gene editing and penetrator technologies.[i] The barriers arise from governance structures, political cultures, science policy and lack of funding pathways which deter independent research and science and expert knowledge.

GMOs and gene edited organisms, together with chemicals and increased use of trace or heavy metals, are known as novel entities:

“new substances, new forms of existing substances and modified life forms that have the potential for unwanted geophysical and/or biological effects… These potentially include chemicals and other new types of engineered materials or organisms not previously known to the Earth system as well as naturally occurring elements (for example, heavy metals) mobilized by anthropogenic activities”.

Stockholm Environment Institute scientists recently proposed that

‘annual production and releases [of novel entities] are increasing at a pace that outstrips the global capacity for assessment and monitoring.’

Current regulatory protocols fail to require independent reviews of the changing scientific literature which might contradict biotechnology-as-safe narratives; and the absence of funding ensure appropriate feedback loops are not established which could funnel monitoring and research information back into the regulatory environment concerning novel entities that are currently released into the environment and into human bodies.

The effect is that the government can neither predict risk or harm, nor steward these technologies precautionarily, in order to ensure that the principles of the Treaty of Waitangi are upheld.

REGULATING PROCESS

Despite media rhetoric, our legislation is good, as it recognises the simple fact that scientists, lawmakers and the public simply do not know what new techniques lie around the corner.

New Zealand’s existing legislation augmented with local government involvement in key regions of genetically modified organisms (GMOs), including newer gene editing technologies, is robust and fit for purpose.

This is where New Zealand stands:

Gene editing processes trigger regulation. Regulation of technology in relation to airlines, chemicals, cars etc is common^[ii] and important.
Our regulation aligns with a recent European Union court decision. It has been held that newer gene editing technologies require regulation, just like the older techniques of genetic modification.
Our legislation is precautionary which thus does not permit automatic releases into the environment. As many unanticipated problems continue to arise with both the older techniques and with new techniques, the precautionary principle continues to be the best mechanism to protect human and environmental health.
Our oversight can improve – to recognise the risk from the potential for technologies to quickly scale up.

By regulating the process (as opposed to a product or novelty), New Zealand should have across the board transparency as we regulate all genetic engineering processes – as do the majority of countries in the world which are united under the Cartagena Protocol for Biosafety.

As our monitoring is limited, public discussions are often weighted to industry-based perspectives, bioethics issues remain out in the cold. Similarly, our regulation can be improved, and take into account the scalability of technologies.

THE SCALABILITY IMPACT

Biotechnologies continue to require regulation and oversight because of their potential to be emitted or deployed at scale, whether in medicine, personal care, agriculture in pest control or for other applications. However, current regulatory triggers don’t allow for risk from release or deployment at scale, and scientists have proposed that a scale trigger can be embedded in regulation. [iii] Scale is explained here:

‘Scale is a complex concept that differs in meaning across disciplines. It is not exclusively a measure of distance, area, volume, and time but also a mixture of these and their relationship with human activity. Where human activity intersects with the environment, there is risk, putting the intersection at the place where we may best control risks of our own making. The highest priority for technology regulation, after deciding to adopt a technology, are harmful or beneficial effects that scale up quickly and/or widely as a result of human activity.’[iv]

However, as the ‘scale of control afforded by science advances, so does the domain of uncertainty and potential risk.’[v] The rationale for continued oversight of biotechnology was outlined by Professor Jack Heinemann, from the Centre for Integrated Research in Biosafety, in a 2021 submission [vi] which looked at definitions of gene technology:

‘Describing techniques of gene technology by their biochemistry, whether it be the reactions that lead to the insertion of a ‘transgene’ and the reactions that lead to genome editing, provides little clarity for technology governance.

The characteristic of the technology that justifies social governance through legislation is that it can amplify the rate and magnitude of harm by increasing the ease of use, number of people using it, range of types of organisms and numbers of individuals it is used on, and the number of environments where it can be applied.’

Heinemann’s work on scalability and uncertainty complements Dr Jan Wright’s criteria[vii] in for judging the for an environmental threat to cause harm, the degree to which it might be:

irreversible
cumulative – building up over time
large in scale or pervasive
increasing or even accelerating in scale and/or distribution
likely to tip a natural system over a threshold into another state

Another problem when it comes to ensuring the safe regulation of biotechnology is the persistent dilemma (with all environmental harms) that harm and risk are difficult to predict. In such an environment, decision-making using the precautionary principle can aide officials. However, in New Zealand, implementation of the precautionary principle is inconsistent and poor, and there has been little work undertaken to develop frameworks and understandings that might support officials.

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REFERENCES

[i] Described in this new paper from the University of Canterbury the New Zealand Defence Agency

Heinemann, J.A.; Walker, S. Environmentally applied nucleic acids and proteins for purposes of engineering changes to genes and other genetic material. Biosafety Health 2019;1:113-123

^[ii] Heinemann, JA. Is product-based regulation of biotechnology code for no regulation? Rightbiotech. https://rightbiotech.tumblr.com/post/178959072080/is-product-based-regulation-of-biotechnology-code

[iii] Heinemann, JA, Paull DJ, Walker S, Kurenbach B. 2021. Differentiated impacts of human interventions on nature: Scaling the conversation on regulation of gene technologies. Elem Sci Anth, 9: 1. https://doi.org/10.1525/elementa.2021.00086

[iv] Heinemann, JA, Paull DJ, Walker S, Kurenbach B. 2021. Differentiated impacts of human interventions on nature: Scaling the conversation on regulation of gene technologies. Elem Sci Anth, 9: 1. https://doi.org/10.1525/elementa.2021.00086

[v] Montenegro de Wit, M. 2020. Democratizing CRISPR? Stories, practices, and politics of science and governance on the agricultural gene editing frontier. Elementa: Science of the Anthropocene 8: 9. DOI: http://

dx.doi.org/10.1525/elementa.405.

[vi] Heinemann JA. 2021. Submission on Proposal P1055 Definitions of Gene Technology. November 2021. Technical Report. DOI:10.13140/RG.2.2.26196.32647

[vii] Parliamentary Commissioner for the Environment (2010). How clean is New Zealand? Measuring and reporting on the health of our environment https://pce.parliament.nz/media/kcvdylib/how-clean-is-new-zealand3.pdf

BIOTECHNOLOGY & GENE EDITING: New Zealand context (2023)

EXCERPT FROM THE 2023 PAPER: Deregulation? Biotechnology & gene editing: New Zealand context. PDF

INTRODUCTION

REGULATING PROCESS

REFERENCES

Information