Precautionary Principle

In order to protect the environment, the precautionary approach shall be applied widely by States according to their capabilities. Where there are threats of serious or irreversible damage, lack of full scientific certainty shall not be used as a reason for postponing cost-effective measures to prevent environmental degradation. (UNCED 1992)

When Germany established the Clean Air Act in 1974, it included the requirement for Vorsorgeprinzip, or foresight. This was the first formal application of the precautionary principle.

In 1992 the Precautionary Principle was included in the Rio Declaration on Environment and Development, to aid UN member states with the protection of the environment and the prevention of environmental degradation. The step to incorporate the Precautionary Principle to protect human health, in addition to an obligation to prevent environmental harm, was taken in 2005 by UNESCO:

When human activities may lead to morally unacceptable harm that is scientifically plausible but uncertain, actions shall be taken to avoid or diminish that harm. Morally unacceptable harm refers to harm to humans or the environment that is:

Threatening to human life or health; or

Serious and effectively irreversible; or

Inequitable to present or future generations; or

Imposed without adequate consideration of the human rights of those affected.

The judgement of plausibility should be grounded in scientific analysis. Analysis should be ongoing so that chosen actions are subject to review. Uncertainty may apply to, but need not be limited to, causality or the bounds of the possible harm.

Actions are interventions that are undertaken before harm occurs that seek to avoid or diminish the harm. Actions should be chosen that are proportional to the seriousness of the potential harm, with consideration of their positive and negative consequences, and with an assessment of the moral implications of both action and inaction. The choice of action should be the result of a participatory process. (UNESCO 2005, p.14)

The Cartagena Protocol on Biosafety to the Convention on Biological Diversity reaffirmed the precautionary approach contained in Principle 15 of the Rio Declaration on Environment and Development (1992).

Principle 15 In order to protect the environment, the precautionary approach shall be widely applied by States according to their capabilities. Where there are threats of serious or irreversible damage, lack of full scientific certainty shall not be used as a reason for postponing cost-effective measures to prevent environmental degradation.

The objective of the Cartagena Protocol is set out in Article 1 as follows:

In accordance with the precautionary approach contained in Principle 15 of the Rio Declaration on Environment and Development, the objective of this Protocol is to contribute to ensuring an adequate level of protection in the field of safe transfer, handling and use of living modified organisms resulting from modern biotechnology that may have adverse effects on the conservation and sustainable use of biological diversity, taking into account risks to human health, and specifically focusing on transboundary movements.

The precautionary principle is detailed in Article 191 of the Treaty on the Functioning of the European Union, page C 202/132 where it is mentioned once.

Union policy on the environment shall aim at a high level of protection taking into account the diversity of situations in the various regions of the Union. It shall be based on the precautionary principle and on the principles that preventive action should be taken, that environmental damage should as a priority be rectified at source and that the polluter should pay.

The European Commission further clarify in the document: Brussels, 2.2.2000 COM(2000) 1 final COMMUNICATION FROM THE COMMISSION on the precautionary principle that (page 3):

Where action is deemed necessary, measures based on the precautionary principle should be, inter alia:

proportional to the chosen level of protection,

non-discriminatory in their application,

consistent with similar measures already taken, based on an examination of the potential benefits and costs of action or lack of action (including, where appropriate and feasible, an economic cost/benefit analysis),

subject to review, in the light of new scientific data, and

capable of assigning responsibility for producing the scientific evidence necessary for a more comprehensive risk assessment.

Karlsson, O., Rocklov, J., Lehoux, A., Bergquist, J., Rutgersson, A., Blunt, M., & Birnbaum, L. (2020). The human exposome and health in the Anthropocene. International Journal of Epidemiology, 1-12.

WHY THE PRECAUTIONARY PRINCIPLE IS A USEFUL POLICY TOOL

In 2004 the World Health Organization released a white paper: The precautionary principle: protecting public health, the environment and the future of our children. Key findings (pages 3-6, edited/abridged):

The PP helps people navigate uncertainty. As “modern” potential risk factors become more complex and far-reaching, the precautionary principle addresses uncertain risks and seeks to shift the ways in which science informs policy from a strategy of “reaction” to a strategy of “precaution”. Together with related approaches such as health impact assessment, precaution provides a useful means of guiding public health decisions under conditions of uncertainty, in a manner that appropriately addresses the issues of power, ownership, equity and dignity.

The PP supports policy-makers and officials in decision-making. Substantial evidence supports the conclusion that contemporary environmental health risks result from complex interactions among genetic, nutritional, environmental and socioeconomic factors. The precautionary principle can be used to encourage research, innovation and cross-disciplinary problem-solving in the face of these complex risks.

The PP helps clarify the role of environmental science in policy-making. This includes policy-making and evidence-based decision-making and how to weigh and judge evidence.

There is no contradiction between pursuing scientific progress and taking precautionary action. Indeed, applying precaution demands more rigorous science in order to characterize complex risks, clarify gaps in knowledge and identify early warnings and unintended consequences of actions. It also means using science not only for the diagnosis of environmental hazards but to identify, develop and assess safer alternatives to potentially harmful activities.

The PP is especially important in countries with weaker regulatory jurisdictions, including developing countries. The PP can inform decisions under the great uncertainty that prevails, can help build public confidence, can raise research and innovation capacities, can ensure that mistakes made in the past in industrialized countries are not repeated, and can help shift burdens from the public institutions to those creating the risks.

There is no single recipe for applying precaution. Flexibility in applying precaution is critically important, since each decision is different – with different types of risk, evidence, uncertainty, affected communities, availability of alternatives, and technical and financial resources. Consistency thus comes from using the same precautionary framework and process in each case. What is considered an “acceptable risk” or sufficient evidence to act is a function not only of the level of risk and the strength of evidence and uncertainty, but also of the magnitude, reversibility and distribution of the risk, the availability of opportunities to prevent risk, the public’s risk aversion, society’s culture and values, and the pros and cons of alternative options.

Preventive precautionary actions aim at continuously reducing and if possible, removing exposures to potentially harmful substances, activities and other conditions.

- encourage the replacement of dangerous substances and activities with less dangerous substances or technologies where suitable alternatives are available;

- reconsider production processes, products and human activities so as to minimize significant adverse effects on health and the environment.

- establish public health goals for protecting the health of humans and ecosystems (such as for reducing blood lead levels or improving fisheries);

- provide information and education to the public to promote empowerment and accountability;

- integrate precautionary considerations into the research agenda to facilitate rapid interventions to prevent damage to health; and

- minimize, so far as possible, unintended adverse consequences that may be caused by precautionary actions.

PRECAUTION IN NEW ZEALAND – GMO/HAZARDOUS SUBSTANCES

New Zealand ratified the Cartagena Protocol for Biosafety in 2005. New Zealand was one of the 175 countries who signed the 1992 Rio declaration.

In such an environment, information and guidance on the application of the precautionary principle can support policy and decision-making by officials. In New Zealand, implementation of the precautionary principle is inconsistent and poor. There is no evidence of policy work/briefings undertaken to develop decision-making frameworks and guidelines, and make such information generally available and easily accessible to officials (including legal counsel) across central government agencies, or who work for territorial and local authorities.

Hazardous Substances and New Organisms (HSNO) Act 1996 specifies (s.7)

'All persons exercising functions, powers, and duties under this Act including, but not limited to, functions, powers, and duties under sections 28A, 29, 32, 38, 45, and 48, shall take into account the need for caution in managing adverse effects where there is scientific and technical uncertainty about those effects.'

Government officials would be unlikely to consider precaution without guidance.

The Ministry for the Environment administers the HSNO Act, but has not produced guidance material for officials or for the public, relating to their obligation to take caution into account.

Since 1996 the New Zealand Environmental Protection Authority (NZEPA) does not appear to have released guidance for officials in taking a precautionary approach. The NZEPA operates under the HSNO Act, but their Risk Assessment Methodology (Updated 2022) does not provide a decision-making pathway to support decision-making when there is scientific and technical uncertainty about the potential adverse effects from the hazardous substances (biotechnologies and hazardous chemicals) stewarded by that Authority.

The lack of resource materials to support government officials in the use of the Precautionary Principle may not only lead to officials under-appreciating the tool - this may be a determining factor in the Precautionary Principle deliberately being set aside (in 2024-2025) by New Zealand's Attorney General, Judith Collins. Government officials and the Crown Law Office may be deliberately excluding the Precautionary Principle in proposed legislation which will aim to steward the release of biotechnologies into New Zealand's environment. The public, academia and media lack a language/expertise on this issue, and this issue is rarely addressed by public law experts and so push-back is unlikely.

Such an action would likely contradict New Zealand's commitment as per the Cartagena Protocol for Biosafety.

2024 COURT DECISION - SOUTH AFRICA

In a 2024 South African Supreme Court of Appeal judgement, African Centre for Biodiversity NPC v Minister of Agriculture, Forestry and Fisheries and Others five judges unanimously ruled that evidence provided by the applicant (in this case Monsanto) in support of a gene edited maize (MON87460) was inadequate to prove safety of the product. The African Centre for Biodiversity's appeal was upheld:

The thrust of the appellant’s case is that the State respondents accepted, at face value, the claims made by Monsanto and failed to independently and critically evaluate Monsanto’s application to satisfy themselves that the health and safety risks associated with the general release of MON87460 had been properly addressed. The appellant contends that the expert evidence that served before the State respondents, ought to have triggered the application of the precautionary principle enshrined in s 2 of NEMA. This, for two main reasons: first, there was a lack of scientific data from which conclusions about the safety of MON87460 could be drawn; and second, the 7 data that had been made available supported concerns about health risks arising from the use of MON87460.'

The precautionary principle was triggered and ought to have been applied.

WITHOUT MONITORING & RESEARCH FUNDING, ARE WE 'RIDING BLIND'?

Relative ignorance concerning the application of the precautionary principle dovetails with underfunding for monitoring and scientific research on risk of technologies. These issues are two sides of the same coin. While governments have provided funding for biotechnology research and development to support release onto the market of biotechnologies, they have vastly underfunded research to identify risks and harms that might be associated with the development and release of these GMOs, including GMOs created using modern gene editing techniques.

The speed of production and release of novel entities, which include man-made chemicals and genetically modified organisms (GMOs), exceeds the pace of monitoring and risk assessment. A small range of crops have been commercialised globally. In the last 25 years, GM crop production has experienced over 100-fold increase. The pace and scale is particularly notable with newer gene editing techniques, which have amplified development speed and shortened the bench-to-market timeline. Academia has joined with industry in the rush to commercialise the technologies (here and here) used along the development chain. Whether a patented food crop reaches the market is highly dependent on the success of trials, including the extent to which transparency in trial outcomes is demanded by government regulators. Trials should not only test for dietary safety, but should include tests for crop vulnerability to unintended disease outcomes, for impact on non-target organisms and for yield.

If governments can fund research and development using new gene editing technologies, they can fund risk-based research. The New Zealand government does not provide funding for long-term interdisciplinary research. Without recognised expertise, media, officials and the courts cannot develop a language of risk and precaution. They are unlikely to turn repeatedly to a single expert. When very few independent experts, who have no conflicts of interest, are willing to speak about risks, these experts can become sidelined or ostracised, simply for pointing out actual or potential hazards.

Empty funding pots for long term, interdisciplinary, risk-based research is not an exclusive problem for would-be GMO researchers. The funding black hole encompasses a much wider spectrum of technology-based harm. This includes exploring risk from hazardous substances (such as pesticides or fluoride) and risk from electromagnetic radiation (EMR) exposures. The barriers limit discovery into how technology might be impacting productivity and economic growth. For example, without long-term funding, local scientists cannot assess how diets high in ultraprocessed foods drive a wide range of disease including neurological disorders, and explore how ultraprocessed foods hasten environmental degradation.

Funding is available to develop new, gene-manipulated organisms, to create new food-based technologies, and technologies and systems which integrate wireless communication and surveillance technologies. Funding is not available to monitor and assess their risks.

It is important to recognise that the absence of funding pathways creates a dearth of experts who can raise issues about risk from technologies, their emissions and their impact on vulnerable or non-target organisms.

For decades young scientists have studied biology and ecology, often with the thought that by studying how life works, from the cellular to the ecosystem level, their research may support human endeavours to protect planetary life, from the cellular level to the functioning of ecosystems.

People want to monitor and identify how harm is created so that governments are informed, and human health and our ecosystems can be protected. But many young scientists find it impossible to monitor and research these issues, because the funding frameworks instead steer them towards research in innovation and pipeline development.

Research on risk is vital, but it is barely happening. This research needs to be funded and the work carried out a safe distance from the developers and patent-holders.

REGULATORY AGENCIES CAN USE NEW TECHNOLOGIES TO ESTIMATE HOW HARM CAN, AND MIGHT, OCCUR

Governance risks are frequently complex, uncertain and ambiguous. Safe regulation of technologies is an especially complex endeavour. The decisions made by governments, scientists and regulatory authorities are values-based. At what level of potential or demonstrable harm do we say 'no more' when man-made technologies interact with open-ended biological systems?

This depends on expertise and the curiosity and values of the policy-maker and researcher. Does that official have the capacity and willingness to recognise and publicly discuss perhaps-controversial risk-based issues when they arise in the literature? This can include focussing on the developmental origins of health and disease, and integrating new information relating to genetic and epigenetic impacts, neurodevelopmental/neurodegenerative risks, cancer risk and endocrine (hormone-level) impacts when published in the scientific literature.

Precaution is based on our capacity to anticipate harm. While companies use the latest technologies to develop their products, regulatory authorities do not proactively integrate new technologies, such as metabolomics analyses and metabolic enrichment pathway analysis into regulatory assessment to assess risks from the technologies they are charged with stewarding.

Why aren't new technologies adopted to assess the risk from gene edited foods?

The Food Standards Authority of Australia and New Zealand (FSANZ) is currently part of the way through a years long P1055 consultation, where the FSANZ believe that many new gene edited foods are substantially equivalent to conventionally produced foods and do not require (precautionary) pre-market approval. PSGR's submission heavily critiqued this FSANZ belief, emphasising that the reports claiming this by FSANZ lacked appropriate rigor (there were no systematic reviews to demonstrate how potential risk was impartially assessed).

Institutions such as the NZEPA and FSANZ could be doing much more work to explore and understand how pesticides and newer gene edited technologies may produce dietary and ecosystem risks. Hoeppers et al (2024) recently modelled how outdoor gene-editing could impact non-target organisms. The researchers used the in silico tools used by genetic engineers to predict efficacy, to assess the potential for non-target organisms to also be impacted from the outdoor gene-editing process.

Hoepers AM, Heinemann JA, Zanatta CB, Chu P, Hiscox TC, Agapito-Tenfen SZ (2024) Predicted multispecies unintended effects from outdoor genome editing Ecotoxicology and Environmental Safety 282, 1 September 2024, 116707.

In a 2022 Public consultation on the Food Regulatory System Strategic Plan (Australia, 2022) PSGR discussed how omics technologies might be applied in risk assessment science.:

Omics technologies (adductomics, epigenomics, proteomics, metabolomics and transcriptomics) traverse a broader biological space, and can complement the traditional biomarker endpoints and play an important role in understanding mixture effects, and the early molecular events in the pathways leading to disease which to date has been largely excluded from regulatory considerations.

Such technologies can help scientists predict systems level impact, whether at the cellular level, the metabolic and organism level, or at the level of a given system (i.e. an ecosystem or population-based level). But these sorts of technologies are currently outside the skillsets (and funding programmes) of technologies and emissions regulators. These regulatory agencies rarely engage in cross-talk with non-industry scientific experts who research risk, but extensively engage in cross-talk with the industry groups who apply for market access and supply the data for risk assessments.

ARE REGULATORS HAMSTRUNG BY CONVENTIONS WHICH PRIORITISE INDUSTRY DATA?

Without the autonomy to investigate and review new scientific understandings, regulators default to industry data using regulatory guidelines which ensures that supplied data conforms to guideline parameters.

PSGR consider that when regulatory guidelines fail to acknowledge new risks, and cling on to antiquated modelling rules instead of integrating new information and acknowledging new pathways of harm, the data supplied by corporate industry may be more accurately be described as propaganda.

‘Propagandistic practices such as secrecy, misdirection and silence effectively corrupt constitutions of countries and therefore their public law principles. These practices effectively allow government officials to abandon legal norms of transparency and accountability.’

We reiterate, in New Zealand, funding pathways to assess actual and potential harms of biotechnologies, hazardous substances and EMR over time do not currently exist. Only overseas data and publications on risk assessment can be used to broaden knowledge on this topic. So, they are unlikely to be studied.

Government officials, and the courts require independent experts, but the lack of funding has hampered this research. The identification of how a technology might be hazardous and cause harm, and the likelihood of a harm occurring (the risk) is challenging, particularly if harms occur at the biochemical level, which can result in slow-moving but significant harms over time (such as inter-generationally, for the species which might be impacted).

Scientists will be familiar with the Mertonian norms - communism, universalism, disinterestedness, and organized scepticism. Regulatory science is an inherently political endeavour - vulnerable to challenges by special interests; predominantly path dependent; culturally situated and dependent on (local and global) peer-group values. These factors (and more) interact to shape how regulatory agencies approach and determine risk and hazard over time.

WHAT HAPPENS WHEN RISK IS NOT RECOGNISED, AND 'REGULATED OUT' OF EXISTENCE?

Aspects of risk can fail to be recognised because such factors are outside guideline. A single class of pesticides which accrue in ground-water is not considered an accumulative risk. Cumulative mixtures of man-made chemicals released in urban waste-water are not assessed for toxicity. Herbicides which synergistically promote antibiotic resistance are not considered in risk assessment. The risks from GMO technologies released at scale and pace are not evaluated. Trials for the COVID-19 genetic vaccine failed to screen for carcinogenicity risk. Non-ionic EMF exposures are not considered a hazard.

This undone science results in regulators not having to apply the precautionary principle with regards to these risks, as scientific knowledge is outside the boundaries of risk.

How might the Precautionary Principle be applied if, for example, the Food Standards Authority of Australia and New Zealand (FSANZ) decides that most gene edited organisms in our food will be of equivalent risk to conventionally bred organisms, and therefore be excluded from pre-market assessment? FSANZ legislation does not require the Precautionary Principle to be applied in their decision-making. It appears as if the Precautionary Principle will be undermined if this decision is taken, as gene edited organisms would likely be recategorized into a different risk bracket.

The FSANZ has arrived at such a belief by producing reports that don't adhere to the fundamental principles that define the advancement of science. No reports transparently declare how the FSANZ searched the scientific literature, reviewed the quality of the publications, so as to arrive at a belief of substantial equivalence. Trust in science is based on the following of fundamental norms which are democratic in nature, they not only promote transparency and accountability, but ensure there is a place where controversial and contested claims can be publicly debated. Regulatory agencies which permit submissions for consultation, but do not address the concerns of submitters, effectively short-circuit this process.

THE PRECAUTIONARY PRINCIPLE DURING COVID-19.

The precautionary principle is relevant to public health,

'because it can help to prevent unintended consequences of well-intentioned public health interventions by ensuring a more thorough assessment of the problems and proposed solutions'.

Historically, the precautionary principle applies to the prevention of a particular activity taking place. Health is protected by reducing or stopping harmful exposures. Kriebel et al (2001) noted the different challenges presented: Concluding a phenomenon or association exists when in truth it does not (a Type I error), failing to detect something that actually does exist (a Type II error). Type I errors are guarded by setting the error rate low (5%) while Type II errors set the error rate higher (20%). 'The test is set up to be more cautious about falsely detecting something than about failing to detect something.' Then there is a Type III error - when one provides an accurate answer to the wrong problem, i.e. looking in the wrong place. Health effects from exposures can be difficult to accurately assess.

Interventions in a public health emergency, to act when information is uncertain to implement a pharmaceutical or non-pharmaceutical intervention broadly across a population, is a misapplication of the precautionary principle. The temptation is to over-state risks from the pathogen, and under-state risks from the intervention, in order to secure public confidence and consequently, public compliance with the measures.

During COVID-19 government policies pivoted to enact rules as interventions at the population level. There was no discretion by age or stage. Vulnerable, young people and children were required to submit to interventions in order to socially interact and to access public institutions. Unfortunately, the problem discussed above, where scientists are not funded to produce information that might contradict the policies of governments, equally applied during COVID-19.

During COVID-19 governments applied the precautionary principle in making decisions about whether to restrict free movement, such as in Canada, by enforcing the mandatory quarantining of travellers who arrive by air in a country, when a global health event has been determined.

In New Zealand Judge Cooke cited the Canadian case of quarantining when discussing the use of the precautionary principle and the importance of acting to protect public health, 'based on the best available scientific evidence'. The Judge noted:

Viewed in light of the precautionary principle, the fact that the Order may not provide perfect protection is not particularly significant. The evidence shows that the challenged measures are a rational response to a real and imminent threat to public health, and any temporary suspension of them would inevitably reduce the effectiveness of this additional layer of protection. This, in turn, would have a significant – perhaps deadly – effect on the wider Canadian public, based on the experience thus far.'

As the New Zealand's judges' comment reveals, the judge viewed COVID-19 in late 2021-early 2022 as a 'real and imminent threat to public health' at the population level. The judiciary and the public were broadly unaware of information in March (and here) and October 2020 that demonstrated that SARS-COV-2 was less harmful than the World Health Organization claimed. The judiciary and the public were possibly unaware that a pandemic could be announced that did not presume a high death rate. Before mandates arrived in New Zealand, it was understood that COVID-19 hospitalisation and death risk was exceedingly low for children and adults. However, it was unlikely that government officials charged with oversight of the pandemic were disclosing this information in the courts, while judges would struggle to value and weight information that contradicted official statements.

Historic understandings that restriction of freedom of movement and compulsory medicalisation could have (often difficult to establish) different adverse consequences by age, stage, socio-economic status and the extent to which isolated people would be socially supported, were set aside. Different sub-groups could be adversely harmed by the states' policies (resulting in net harm - reduced health equity) where they might have been unharmed, or less harmed, if exposed to the pathogen.

A judge that believes a pathogen has broad existential risk across an entire population will view that their action to uphold mandates regarding non-pharmaceutical and pharmaceutical interventions is precautionary, and will be unlikely to interpret precaution from taking contradictory or controversial measures that would conflict with peers in the courts or government.

It is noteworthy that during COVID-19, authorities interpreted the 'best available scientific evidence' but failed to give weight to formerly established public health policies on norms on population management from a highly transmissible respiratory, influenza-type virus, based on changing evidence of risk of hospitalisation and death by age. In 2019, the Global Influenza Programme stressed non-pharmaceutical measures. Contrary to historic norms, in 2020-2023, public health surveillance systems equated risk with infectivity rather than hospitalisation and death risk.

Proportionality, even though outlined in overarching legislation, was not debated, nor was scientifically established evidence relating to the pattern of infectivity, pathogenicity and host-resistance or susceptibility. Historic norms which recognised that healthy people would play a role in a population achieving natural immunity, and that natural immunity provided broad-based protection were not accepted.

Interventions (including the role of employer mandates) excised personal choice and obstructed informed consent, the capacity of a person to judge their own risk and make a decision based on their best available evidence. Early on in the pandemic, respected public health scientists released a statement urging that lockdowns and restrictions cease, because of the risk of creating far more harm, than the harm authorities sought to prevent. They were publicly vilified, despite their respected academic backgrounds.

Drugs and nutrients with a long history of safe use and clear knowledge about side effects, i.e. that reflected long-held precautionary norms held by the medical community, first do no harm, were broadly dismissed by health and regulatory agencies due an absence of randomised control trials specifically concerning COVID-19. As COVID-19 was a respiratory virus with known thrombotic effects, scientists and doctors globally advocated for precautionary measures to prevent viral replication, and reduce the likelihood of disease progression, and hospitalisation in vulnerable groups. They were unsuccessful. Advice from medical doctors urging precaution in submissions to a major New Zealand consultation, went unheeded in the committee report.

Governments were reluctant to permit discussion which might promote public doubt on the states' choice of intervention, and states often created barriers to both declaring an adverse event, but also sourcing information about the possibility of risks and the extent of adverse events. Contamination was an identified risk of biologic drugs (and may be the case with the COVID-19 injection), and their mode of action is different from conventional immunisations. The public probably weren't aware that mandates centred around a biologic drug that encoded genetic information, instructing the body to produce a potentially harmful protein, where the production of that protein (the dose) was uncertain, for which a trial was cut short and the placebo group muddied, and for which efficacy centred around two weeks of not getting a cold after the second dose and for which there were no carcinogenicity studies.

Principles of democratic, constitutional and constitutional equity laws which also define the advancement of science and promotes and sustains trust in governing bodies - transparency, impartiality and accountability - were sidelined.

The government did not undertake systemic reviews of the scientific literature, which would include disclosure on how the scientific information was selected and weighted. 'Science Updates' contained no disclosure of any systemic analysis of the relevant literature. There was no disclosure of the scale of adverse events observed in February 2021 by the company with market access in New Zealand, that was reported to the government, but not publicly disclosed. The under-reporting of vaccine-injury was a recognised problem, and this was a completely novel biotechnology implemented at scale and pace.

The process in New Zealand of the mandate rollout was legislated via secondary legislation by the Minister in charge, but there was no requirement for a review of the independently published evidence base for safety and efficacy, by age and status for each new tranche of legislation as the months progressed.

In effect, the precautionary principle if applied, was not applied using traditional evidence-based collation of information, that conformed to principles of scientific rigour and that ensured that the principle of first do no harm, would be a guiding value.

The example of COVID-19, where interventions were enacted under emergency provisions, where critical or dissident scientists were not funded to research risk in COVID-19, and not permitted to engage in debate with senior policy-advisers, politicians and the Director-General of Health, where healthy young people were required to submit to the same measures as frail older people, where uncertainty acted in favour of compulsory, population-wide interventions, - this example has potential to serve as a precedent for future public health emergencies.

The Precautionary Principle, Uncertainty & Tech-Based Risks

Karlsson, O., Rocklov, J., Lehoux, A., Bergquist, J., Rutgersson, A., Blunt, M., & Birnbaum, L. (2020). The human exposome and health in the Anthropocene. International Journal of Epidemiology, 1-12.