When Parliament is misdirected – A case for regulatory failure?

The western world is witnessing a steady corruption of laws and processes, with governments ‘bending’ our institutions to serve the interests of powerful industries and institutions.

New laws that claim to govern new technologies and safeguard the public interest, are watered down to such an extent that they cannot achieve the purported aims of that legislation – they are corrupted from the get-go.

Government statutes intended to regulate a technology or its emissions may contain noble purposes, but the underlying text can be so poorly drafted that legislation lacks ‘teeth’ to ensure that, for example, human and environmental health can be protected. From failing to provide a language around risk and harm, to explicitly constraining the behaviour of the people acting under that legislation. When the statute is obtuse, taking an official to court for regulatory or judicial review becomes impossible. When statutes implicitly and explicitly constrain regulatory powers to prevent inquiry, safe governance of emerging technologies including gene edited technologies, is impossible.

New Zealand’s proposed Gene Technology Bill cannot result in legislation that will achieve the purpose of the safe use of gene technologies and regulated organisms. The Bill was drafted by the Ministry of Business Innovation and Employment (MBIE), the Hon Judith Collins and Crown Law. The legislation is marked by what has been excluded.

Public input to the Bill can be sent to the Health Select Committee by February 17, 2025.

It appears that the so-called ‘bespoke legislative regime’ described in the Bill is unfit and cannot achieve its stated purposes.

Unfortunately, if members of Parliament (MPs) and their communities don’t understand what is happening at an early stage, faulty bills can become law.

A BIOTECH INDUSTRY CARVE-OUT

The Bill’s release follows decades of lobbying by the biotech industry and government research institutions funded to study biotech. New Zealand’s proposed regulatory regime explicitly caters to the demands of biotechnology companies and developers. The Bill was released over our southern summer, while Parliament is in recess, and uncomfortable questions can’t be asked of the member of Parliament who is in charge of the Bill, Judith Collins.

A broad swathe of gene edited organisms have been regally declared by MBIE and Collins to be ‘indistinguishable’ and exempt or ‘very low-risk ’ and non-notifiable. The Bill actively undermines New Zealand’s regulatory status because it will ‘disappear’ many gene edited organisms, including food, from regulation, tracking, tracing and obscure public knowledge. Essentially, MBIE’s new definitions would write out entire classes of genetically modified organisms.

The benchmark of what produces the ‘indistinguishable’ or ‘very low-risk ’ status is strangely not defined in what would become primary legislation. In the policies, such statements rely on pseudo-scientific claims which are not backed up by a thorough assessment that has gone through any form of peer review by scientists without skin in the game.

MBIEs lordly and hypocritical approach is extraordinary. Instead of charging Regulator with the powers and discretion to evaluate and re-evaluate low- and high-risk organisms as knowledge changes over time, it’s predetermined and prearranged.

MBIE and Collin’s claims that the legislation will be ‘risk-proportionate’ are groundless. What has been excluded from the Gene Technology Bill is as critical as what has been included. That Regulator should not be bending to the dogma of the innovation-focussed government agency that oversaw the drafting of the legislation. All claims relating to risk and safety must be subject to regulatory scrutiny.

Somewhat contradictorily, MBIE believes that regulations would be flexibly ‘regularly updated’ (because the important bits will be stuck in secondary legislation) – but to serve whom? Do MPs understand how much regulatory scientists will be straightjacketed?

MBIE and Collins have kicked out the principles that are conventionally locked in primary legislation, which are critical for guiding decision-making, but they’ve also tied regulatory scientists hands behind their back.

Paradoxically, in a world where scientific knowledge changes swiftly, MBIE’s Regulator does not have the powers to independently scope for and evaluate new forms of risk. This is particularly the case for the gene edited (GE) organisms pre-declared by MBIE to be exempt or of very low-risk . There are no powers for the Regulator to reevaluate Collins’ and MBIEs’ godlike declarations of indistinguishable and very low-risk.

Additionally, there is no language that addresses the accelerated scale of biotechnology developments and releases, which would, of course, increase in a more deregulated environment. There’s no language that acknowledges that the tech to screen and understand GE contamination in foreign jurisdictions is moving super quickly, and that this tech could be used by our own scientists to assess risks from GE organisms.

Regulation of a technical activity is not a dirty word. The Regulator can conduct a premarket assessment of all gene technology activities. Risk tiering can then take place, using for regulatory processes which take into account hazard and exposure criteria. Some activities that would never be released into the environment could be predetermined as low-risk , but none should be exempt.

ECONOMIC UNCERTAINTY

Collins and MBIE did not assess the extent to which global citizens actively pay a premium for foods and often fibres that are free of contamination from a genetically modified organism – GMO free. This was not factored into impact assessment.

Judith Collins biotech-industry facing legislation has failed to consider the non-biotech economic fallout. The contamination risk that would automatically arise from the deregulated status of microorganisms, plants, fungi, and animals, automatically transfers the risks – as additional costs, uncertainties and instability onto the shoulders of New Zealand’s $54 billion agricultural export industry. Do MPs know that Europe’s current legislative proposals only concern plants?

Many of our markets would be more tightly regulated jurisdictions, if this Bill were passed. Supply chain transparency would be profoundly undermined by the nature and extent of out-of-scope activities that would preclude tracking and tracing.

GOVERNANCE DEBACLE

It remains strange that New Zealand’s Attorney-General has driven this legislative proposal. Officials are required to be politically neutral, consultation must  focus on reducing unintended consequences, and regulatory agencies must take a whole of system view and adopt a systemic and evidence-informed approach to policy development.

As the Cabinet Office Circular states:

Inadequate impact analysis often arises from incomplete problem definition, unclear objectives and a failure to consider all feasible options. As these are key foundations of policy analysis, inadequacies in these areas cannot be easily fixed at a later stage, with consequent impacts on the quality of the impact analysis.

Somehow these requirements have been bypassed. The consultation process was poor, and the policy documents are appalling, and this has spilled over into the Bill text. Economic claims but no economic analysis. No cost-benefit analysis. No scientific assessment to independently validate and justify MBIE’s claims. No technical assessment to explicitly evaluate how deregulation would mirror (or contradict) GE regulations used by our major trading partners. No impact analyses from affected agencies.

PLAYING DOWN RISK AND NON-KNOWLEDGE FOR EMERGING TECH

GE technologies are characterised as an emerging technology, new technologies characterized by radical novelty, relatively fast growth, coherence, prominent impact, and uncertainty. Policy documents and the text of the Bill fail to outline and provide context about the extent of unknown aspects surrounding gene edited (GE) technologies and uncertainties in safely regulating them.

Those writing the policies have not attempted to inform policy-makers or the public on what risks could arise. The policies are strangely silent on how many of the GMOs which are now regulated, would escape regulation and premarket assessment, should the Bill pass. This has not been communicated to members of Parliament, or to the public.

Currently, European gene editing legislation (which explicitly provides that the precautionary principle is taken into account) is at a standstill, because drafting legislation to navigate risk is difficult, and can’t be rushed. European legislators intending to release GMOs (only plants) into the environment, must also take into account Annex II to Directive 2001/18/EC. But apparently in little New Zealand this is OK – and we would release (potentially heritable) genetically modified (GM) microorganisms (including viruses), plants, fungi, and animals.

New Zealand’s hastily drafted Bill has excluded many important issues that are being debated in more tightly regulated jurisdictions.

PRINCIPLES TO GUIDE REGULATION

Governing or stewardship principles would ordinarily be in place to support regulatory decision-making. This helps regulatory scientists to navigate regulatory uncertainty, and uncertainty can be a big problem because ‘risk’ can be difficult to put a finger on. But no overarching principles have been drafted into the Bill to support regulatory scientists and the Regulator in risk assessment.

Regulatory scientists navigate a space between science and policy, a socio-political and scientific ‘no man’s land’. Principles and values drafted into the legislation are important as they help regulatory scientists work in what can be highly politicised environments, to protect the public interest.

As an example, the purpose, principles, matters relevant and the Treaty of Waitangi (clauses 4-8) were drafted into the Hazardous Substances and New Organisms Act 1996 (HSNO Act).

If one turns to the Gene Technology Bill, the purpose is to enable

‘the safe use of gene technologies and regulated organisms by managing their risks to—

(a) the health and safety of people; and

(b)the environment.’

There are no principles or matters relevant to this Act that assist officials to navigate often fraught political waters in the public interest. The USD1.5 trillion biotechnology industry financially benefit from under-regulated environments, while the risk, and contamination costs, are transferred to local communities, governments, non-GMO businesses and consumers.

Biotech want to privatise the profits, while socialising the costs.

The regulatory principles that are needed to protect our nation at this crucial time were in the HSNO Act, but have been purposefully excluded from the Gene Technology Bill.

‘HAVING REGARD FOR’ – NO OBLIGATION IN LAW

The principles, values and ethics appear to be inserted in clause 5 of the Bill, but this is window dressing. Clause 5 merely requires that officials operating under the Act must have ‘regard for the provisions of’ the Convention on Biological Diversity and the Cartagena Protocol.

Having ‘regard for’ does not place an obligation on officials to take a matter into account. Any thoughts about the Convention on Biological Diversity and the Cartagena Protocol may merely be considered and discarded. This is far more likely if there are no overarching principles which help officials to navigate ethically, scientifically tricky and politicised policy and law terrain, so as to make judgements that stand the test of time.

GAMING THE TREATY OF WAITANGI

Consider how the new Gene Technology Bill constrains the Regulator with regards to the Treaty of Waitangi. Whereas previously, higher-level principles were required to be considered, the current Bill instead believes that the Crown’s obligations under the Treaty of Waitangi be served by constraining consideration to a narrow focus. All that is required, is a Māori Advisory Committee, who advise and to only give a specific regulated organism some consideration. Yes, that’s it.

There’ll be no consideration on whether or not it is a ‘fact’ of whether unregulated (exempt) or ‘very low-risk ’ organisms are as benign as we are told, and the Bill drafters seem to believe. The Bill text claims that the principles of the Treaty of Waitangi only need to be taken into account by ‘thinking’ about regulated organisms. What complete poppycock!

The legislation then dives into technical, administrative functions.

LIABILITY PROTECTIONS FOR OFFICIALS

Whereas the HSNO Act did not build in exemptions for civil and criminal liability for officials administering the HSNO Act, the Gene Technology Bill actively builds in protections for officials working under the powers of the Act.

WHY PRINCIPLES ARE IMPORTANT

Scientific controversies tend to revolve around values-based issues, including how uncertainty is navigated. Institutions who benefit financially, habitually downplay risks. Conversely, the public work to ensure that they are protected from hazards that if insufficiently regulated, could become a real risk to human or environmental health.

This is why principles are normally drafted at high levels in primary legislation to ensure that everyone understands what risk proportionate actually means. Principles ensure that rules drafted lower in secondary legislation reflect our values-based understanding of ‘proportionate’, guiding decision-framing by officials.

Principles provide rails upon which our understanding glides, of what hazards and exposures, what level of risk we are prepared to tolerate. From a health risk by age and/or developmental status, to the risk of heritable genes wilding into the environment. Scientific assessments need value-based principles to help establish endpoints and no-go zones.

Guidelines and regulations in that secondary legislation, assist in scientific assessment and reasoning to ensure the technology and its use is both ‘safe’ or ‘risk proportionate’ – but they can only ‘work’ if based on higher level values that are understood by all.

Principles guide the making of sound, valid, trustworthy guidelines, and promote trustworthy decisions. Such decisions ensure that the administration of an Act and how it is governed over the longer term, works for all the people of New Zealand, not just for the deregulation-focussed industry sector.

However, the Bill drafters appear ignorant of these issues.

We have no idea of the extent of evidence reviewed by MBIE, and the knowledge base that underpinned the initial decision around ‘distinguishable’, and no disclosure of how evidence on GMOs would be independently surveilled by the Regulator. Information gained from using scientifically robust methods and peer reviewed published scientific research, should be at the core of assessing what does or does not present as a risk.

THE BILL STRAIGHT-JACKETS (CONSTRAINS) REGULATORY OFFICIALS

By not drafting principles and obligations into the Bill text and predetermining narrow forms of risk assessment, the arms (and minds) of Regulatory scientists and officials will be pinned. The Bill text corrals regulatory scrutiny by limiting what type of risk assessment can be undertaken and constrains who the Regulator might go to, for information.

There is no latitude to consider the published and peer reviewed literature outside of data supplied by the Technical Advisory Group (TAG) or by other regulatory agencies. No capacity to review global court decisions and the data released through the discovery process.

There are no powers for wider information gathering; for questioning by officials of scientific uncertainties, for introspection by officials of risk scenarios outside of Collins and MBIE’s prescriptions, particularly when information in the peer-reviewed literature contradicts beliefs and claims. An example of this would be Collins and MBIE’s assertions concerning indistinguishability and very low-risk , which is dogmatically embedded into the legislation.

Permissions about risk drafted into the Bill seem to exclusively concern assessing the risk of regulated (notifiable) organisms. Other forms of risk for exempt and non-notifiable organisms have simply been ignored.

If they sense risk, officials are left with no pathways for flexible inquiry. Experts can sense risk in many ways – risk to any organism (including consumers), to an environment, or to any number of off-target organisms. Risk from (potentially heritable) DNA rearrangements could impact the health, fertility and intelligence. Predator-prey relationships could be disrupted.

Officials will be left swimming in a swamp of technical processes, but left unable to grasp at any ethical or scientifically rigorous ‘branches’ to climb out of the swamp, and help navigate information, judgement and decision-making.

It looks very much like the guts of this document were drafted offshore by the biotechnology industry and then handballed to Australian lawmakers, to MBIE and Collins.

In order to govern risk, regulators must have the power to ensure that they can undertake two central activities: [a] perform generic risk research and development, related to concepts, theories, frameworks, approaches, principles, methods and models to understand, assess, characterise, communicate and (in a wide sense) manage/govern risk; and conduct [b] risk assessments and risk management (including cost-benefit analysis) to study and treat the risk of specific activities.

The Bill text neither describes [a] and predetermines [b] to exclude a wide range of activities.

UNDERSTANDING RISK – A BROADER CONTEXT IS ESSENTIAL

So, what risks are we prepared to take and what does safety mean? A relevant risk is the ‘health and safety of people’ but what is ‘safe’ remains undefined. Later in the Bill emergency authorisations grant official powers for threats from ‘disease outbreaks, plants, invasive species and industrial spillage’.

But the threat to the long-term health of an organism which was not previously genetically modified, and the threat of off-target harms are not defined. We need to be cautious as most of this is unknowable and unpredictable, because so many unpredictable biological processes which create both hazards and risks are at play.

This has been discussed at Physicians and Scientists for Global Responsibility, a New Zealand-based charitable trust.:

Edits to the genome can include point mutations, small insertions/deletions (indels) and larger deletions of the DNA. Whilst the gene editors may know what they are doing to the DNA, they do not necessarily know what the DNA and hence the cell, will do in response to these DNA interferences.

Point mutations, small insertions/deletions (indels) and larger deletions of the DNA can occur in GM organisms that are classed by Collins and MBIE as ‘exempt’ and ‘very low-risk ’. Massive uncertainty revolves around where real harm might start. When and where we draw a line in the sand about where a genomic edit might cause sufficient harm to an organisms DNA, is not covered in MBIEs unscientific policy papers. Will declarations quietly change and waver in the secondary legislation, like fashions that come and go?

MBIE and Collins’ legislation presumes that people are meant to find a problem and report it, even though there is no guidance to monitor, assess nor judge the extent of a problem. The Minister for Primary Industries is granted powers to monitor regulated organisms, but non-regulated organisms will avoid this.

The technical barriers to scientific assessment of GE contamination and gene flow into the environment are extraordinary not only because the technical instrumentation and expertise required to do such work is expensive. The ways organisms interact in the environment with other organisms is often beyond our powers to predict them. From a virus, to microalgae to a fruiting orchard. This should be evident to everyone, from the Minister, to Crown Law, to me and you. Strangely, the Ministry for Primary Industries have been given powers to monitor (and only the regulated organisms). Why not the Environment Protection Authority? What about the impact on surrounding environments?

This is part of the reason the precautionary principle, process-based assessment, and complete transparency and traceability should be such an important component of regulation.

RISK AT SCALE

How do we understand risk following a government’s deregulation of a technology? What happens when large quantities of regulated and unregulated organisms are released into the environment, particularly when there is absolutely no funding set aside for research about risks from escape of GMOs and subsequent contamination?

RETAINING  PROCESS-BASED REGULATION

The policy formulation process has been extraordinarily poor. The case is not made scientifically, economically or environmentally in any underpinning policy documentation.

The process-based regulatory approach under the HSNO Act should remain. ‘Process-based’ means that regulation is triggered by the gene technology processes involved in the development of an organism rather than the risk presented by resulting GM organism.

Process-based can adopt a risk tiered approach to account the fact that some organisms will be higher risk and some will be lower risk – but necessarily, all organisms must be disclosed. Lower risk does not mean no risk, however.  Any ‘very low-risk ’ organism that ends up causing unforeseen harm that was not expected, becomes a high risk. MBIE have downplayed this regulatory approach.

MBIE’s Regulatory Impact Statement (RIS) claims that the current ‘status quo’ ‘does not anticipate or flexibly accommodate future technological developments to benefit New Zealanders. Under this option all advancements in gene technologies would be subject to regulation regardless of the type of modification or the resulting trait’.

This reasoning upon inspection is incorrect and probably absurd. MBIE assumes that a particular class of gene organisms will never present an environmental or health-based risk. However, the content in the policy does not support these claims.

MANDATORY MEDICINE: DELEGATING POWERS TO OFFSHORE INSTITUTIONS

The mandatory medical authorisation provisions set the stage for abuse of power and serious risks to health. While the legislation could build in an ‘opt in’ provision, the Regulator will instead be compelled to adopt the decisions of offshore regulators. No checks and balances are required, no review of corporate pharmaceutical data, no review of the risk-basis of the disease ‘problem’ the mandate seeks to address, no scope to assess human rights obligations, and no appeals.

Is this even legal?

As PSGR will note in our submission, a ‘mandatory medical authorisation’ fails to require regulators and officials to take into account local factors which may result in there not being a risk in New Zealand that would be sufficient for deploying that technology into mammals including humans. Even if such a risk were to be present, this Bill ignores the use of drugs, nutraceuticals and functional foods that have been shown to be very effective in treating infectious diseases. Is this policy laundering?

The Bill text does not address the risk/s to an individual nor acknowledge human rights.

It appears that any regulatory work on the deployment of mandatory medicine would mimic the COVID-19 vaccine rollout. That rollout was predominantly secretly enacted through secondary legislation, Cabinet officials abstained from requiring evidence on the changing risk-benefit ratio (the nature of the ‘emergency’), failed to calibrate this against risk to the individual and then ordered institutions and employers demand a vaccine-injected status.

This set the stage for total abuse of power, where healthy, not-at-risk people were injected and exposed to a novel technology containing the instructions for self-replicating modified RNA in the form of a spike protein. It has not yet been determined how long this spike protein will go on being made by the body.

Much of the ‘mandatory medical authorisation’ process can be carried out as secondary legislation and bypass Parliamentary process. Cabinet confidentiality hid official decision-making in COVID-19 – and the same could happen with a future medical mandate.

LACKING HUMILITY: AN ARROGANT FORM OF LEGISLATION

There is no scientific review or risk assessment that shows that acceptable processes have been followed to back up their claims. Such processes would ensure that both transparency and accountability were part of the job.

MBIE and Crown law have not defined ’distinguishable’ or ‘indistinguishable’, nor have they made any allowance for their claims to be refuted. Crown law has effectively locked in protections for the patent owners. This is not regulation for health and environment, it is corporate protectionism.

In effect, if passed, MBIE the Environmental Protection Authority and the Ministry for Primary Industries would be left with dangerous, arbitrary of legislation that ignores decades of risk assessment policy and practice. It is designed to never be future-proof.

The existing process-based approach in the HSNO Act has been propagandised as an elderly tyrant. Yet it simply acknowledges that knowledge about the risks of new technologies can change over time and that we must be humble about what we do not know. Ten thousand people submitted to the Royal Commission on Genetic Modification, and after looking through five thousand pages of transcripts, about two hundred recommendations were made. But neither Collins nor MBIE have reviewed the white paper that was released after two years of intensive work by very smart people.

MBIE’s current Bill proposal lacks humility, instead arrogantly presuming that knowledge on risk is settled.

The Bill fails to give the Regulator the powers to develop and maintain a comprehensive understanding of the changing nature of the risks of biotechnology.  This means that the Regulator will be unable to have the foresight to act, so as to protect future generations. The regulator would be predominantly dependent on the regulated industry.

MBIE’s reasoning is circular. It claims its law would be safe and ‘proportionate’ without independent environmental, economic (including biosecurity) or scientific evaluation. This has produced an ephemeral, quick-sand-like Bill that is the inverse of the quality demanded of effective, future-proof regulatory law.

This Bill should be withdrawn, because it has no capacity to establish a framework that can regulate genetically modified organisms (GMOs), including gene edited (GE) organisms for the health and safety of the people of New Zealand now and in future.

I will be concerned about the Select Committee process, as I’ve watched how these committees write out public concerns when issues concern scientific information and human health. Because, after all, you can make science say, whatever you want it to say.

Please read MBIEs’ Regulatory Impact Statement and consider the information on this topic presented by the many groups that share my concern about this Bill and the consequences of this legislation: here, here, here, here, here, here and here.

(Disclosure – I have previously spoken on a panel discussion and was invited to speak on this webinar.)