Why NZDSOS Opposes the Hazardous Substances and New Organisms (HSNO) Amendment Bill

Submission of NZDSOS.com
(New Zealand Doctors Speaking Out with Science)

To: Primary Production Select Committee

On: Hazardous Substances and New Organisms Amendment Bill (304-1)

Date: 15 June 2026

Executive Summary

Instead of weakening the HSNO Act, Parliament must:

1. Investigate how the COVID-19 products were permitted to bypass HSNO oversight.
2. Strengthen the Act to ensure such circumvention cannot happen again.
3. Reject any amendments that prioritise administrative efficiency or commercial opportunity over precaution, public participation, and the protection of human and environmental health.

Introduction

NZDSOS is a group of doctors and other human and animal health scientists who stand for medical ethics and precautionary medicine, and we are duty bound to oppose the de-fanged Hazardous Substances and New Organisms Amendment Bill in its entirety.

We say that the Bill is fundamentally misconceived. It seeks to accelerate approval pathways for hazardous substances and new organisms (including genetically modified organisms) at a time when New Zealand’s regulatory framework has demonstrably failed the public interest. The most compelling evidence of this failure is the manner in which novel COVID-19 mRNA biological products were mis-defined as ‘vaccines’ and thus deployed in New Zealand without receiving scrutiny under the HSNO Act.

The awakening of the NZ public to the ministerial knowledge of the injections’ definite harms – in the face of a clear intention to deceive people otherwise – should be born in mind by all officials but especially MPs on the PPSC. As citizens gain awareness of the capture of swathes of our public institutions by for-profit private corporations, an appetite for understanding and accountability will only grow.

1.  A Pattern of Circumvention: From Gene Technology Bill to HSNO Amendments

This Bill does not exist in isolation. It follows the Government’s failed attempt to pass the Gene Technology Bill, which received 97% opposition from submitters before being put into dry dock. That Bill sought to create a separate, lighter-touch regulatory regime for gene editing and other new genetic technologies. It was parked because the public recognised it for what it was: deregulation disguised as modernisation.

The present HSNO Amendment Bill appears to be a backdoor attempt to achieve the same outcome – industry capture of a vital regulator – without the scrutiny that defeated the Gene Technology Bill. Where that Bill tried to build a new, weaker pathway alongside HSNO, this Bill seeks to hollow out HSNO from within. Both serve the same commercial interests, and both would leave New Zealanders and our environment less protected.

There is a pattern here: when direct legislative capture fails, pursue administrative capture through ambiguous language, delegated powers, weakening protections (and accelerated processes. Examples include the Covid-19 Royal Commission’s advice to go harder next time, and the new Public Service Code’s explicit omission of Bill of Rights obligations. Parliament should not be complicit in this circumvention of democratic accountability.

2.  The Central Failure: HSNO Was Circumvented, Not Used

The Bill is presented as a reform to make the approvals process for hazardous substances and new organisms more “efficient.” Yet it entirely fails to address the most consequential regulatory failure in a generation.

During the COVID-19 response, novel mRNA biological interventions were deployed across the New Zealand population under an alternative regulatory pathway. The HSNO Act – specifically designed to scrutinise new organisms and hazardous substances – was bypassed.

Arguments around the precise wording used by the Act to define if a new therapeutic is a GMO engaging its scrutiny have distracted from the likely intent of parliament at the time it was passed. Had it known that an injection containing artificial gene code which causes the body to output a foreign protein – in some cases indefinitely – was contemplated it would have demanded intense study by the Environmental Protection Agency. We have documented where many politicians, officials and the industry itself have admitted the deeply obvious: The covid-19 modified RNA injections WERE a gene therapy, and an experiment. But the government engaged a couple of scientists to say they were just vaccines. The fix was in.

The consequences are a matter of public record. Medsafe had received over 24,000 reports of serious adverse events and 183 reported deaths following vaccination by the time it suspended its public reporting in December 2022.

The CDC and our own CARM have documented that myocarditis (causing child deaths, the FDA and TGA admit) and other serious adverse events occur with mRNA COVID-19 vaccines. Pfizer’s own data acknowledges serious adverse reactions including death, wide-ranging inflammatory diseases of the brain, heart and other organs, and high rates of fetal loss.

We do not present this data here to establish individual causation – that requires honest assessment of the evidence. But they demonstrate the scale of real-world consequences that followed deployment under an alternative pathway, without the level of precautionary assessment the HSNO Act was designed to provide. Questions concerning carcinogenicity testing, fetal and reproductive toxicity, biodistribution, and long-term safety were not resolved prior to widespread deployment. Tragically, very concerning answers started to emerge almost immediately. Five years on, though, the EPA is in the company of numerous other public agencies that have been silent about this information – in particular Medsafe, the Health Ministry and drug buyer PHARMAC.

None of this can be an argument for faster approvals. Surely there is a powerful case instead for stronger, non-circumventable oversight.

3.  Risk Assessment is Broken – But This Bill Accelerates Anyway

The EPA has itself acknowledged that its risk-assessment models are outdated and no longer fit for purpose. The Ecotoxicology and Toxicology Models Modernisation project (tender review, Reference #32645989) is currently underway, with the UK’s ERM appointed as the implementation partner at a value of $3.16 million. The project’s stated purpose is “to deliver to the EPA modern, fit for purpose models and supporting data, to usefully strengthen our risk assessment processes”.

This review is expected to address a range of ecotoxicology, toxicology, and environmental fate models, data requirements, and environmental assessment factors.

Yet before this review is complete – before Parliament or the public have had any opportunity to consider its findings – the Government is asking us to expand approval pathways that depend upon those very models. This reverses the order of regulatory reform which ought to fix the foundation then build upon it.

4.  The Bill Unlawfully Rewrites the Definition of “New Organism”

The Bill introduces the novel administrative category of “denewed” organisms (Clause 25, new section 25C, and Clause 114, new Part 5A)—an invented word that performs significant legal work without statutory definition. This would grant the EPA power to declare that an organism is not a “new organism,” thereby removing it from HSNO oversight entirely.

This provision directly contradicts the High Court’s finding in Sustainability  Council of New Zealand Trust v Environmental Protection Authority  [2014] NZHC 1067. In that case, Mallon J held that only Cabinet or Parliament, not the EPA, has the authority to determine which techniques and organisms are exempt from the GMO regime. The Court found that the EPA had overstepped its powers by purporting to add gene-editing techniques to the exemption list administratively.

The “denewed” provisions appear designed to retroactively authorise actions the EPA may not have had legal authority to take, and to grant itself new powers that properly belong to Parliament. This is not good law-making, rather it looks like is an attempt to legislate away a binding court decision.

5.  The Royal Commission Ignored Lessons to be Learned

The Royal Commission of Inquiry into COVID-19 Lessons has now reported. Importantly for your select committee, the Commission did not examine whether the novel mRNA products should have been subject to HSNO Act scrutiny – we were clear with the Commission they should have been – so that question remains unanswered by any official inquiry. This gap in itself is concerning. Parliament must not rely on the Commission’s silence on this issue as endorsement of the status quo, and allow further weakening of vital regulations. To proceed with a Bill that expands approval pathways and reduces scrutiny would be to repeat the very failures the Commission was established (but failed) to investigate.

6. Specific Provisions We Oppose

For the reasons set out above, we too oppose particularly the following key provisions:

• Clause 25 (new section 25C) and Clause 114 (new Part 5A) –
  “Denewed” organisms. This grants the EPA power to declare organisms are not new organisms, directly contradicting the High Court’s ruling in Sustainability Council v EPA.
  
• Clause 31 – Increased reliance on overseas approvals without clear
  statutory criteria for assessing the quality, currency, independence, and relevance of those assessments.
  
• Clause 85 (new section 53) – Replacing mandatory public notification
  with a discretionary “significant public interest” test. This transfers control over public participation to the regulator itself, allowing it to determine whether the public should even know an application exists.
  
• Clause 42 (new section 34B) – Conditional-to-unconditional release pathways for new organisms without adequate safeguards.

• Clause 12 – Expanded delegation powers to the EPA Chief Executive and staff, reducing oversight. This autocratic attempt is lifted straight from the Gene Technology Bill.
  
• Any provisions enabling “risk species” classifications through notices rather than primary legislation.
  

7.  Our Request to the Select Committee

We wish that the Committee:

1. Reject the Bill in its current form.
2. Pause any further consideration until the independent ERM review of the EPA’s risk-assessment framework has been completed, publicly released, and subjected to full public consultation.
3. Conduct an inquiry into how COVID-19 mRNA biological interventions were permitted to be deployed in New Zealand without proper HSNO Act scrutiny, and recommend legislative amendments to ensure such circumvention can never happen again, having regard to breaches of BORA and settled international human rights and bioethics legislation.
4. Redraft any future bill to incorporate clear, binding principles of necessity, precaution, mandatory public participation, independent scientific scrutiny, and protection of rights under the New Zealand Bill of Rights Act 1990 – and explicitly to prohibit the “denewing” of organisms determined to be new organisms by the High Court.
   

8.  Conclusion

The COVID-19 injectables still-evolving health disaster demonstrated the profound consequences that can arise when novel biological interventions are deployed before all relevant risks have been identified and assessed. It seems to us that may have been the point, but at any rate the EPA has acknowledged its risk-assessment models are outdated and is spending $3.16 million to modernise them. The High Court has ruled that only Parliament, not the EPA, can decide what is and is not a new organism.

In this context, a Bill that accelerates approvals, reduces public participation, expands administrative discretion, and purports to “denew” organisms that are plainly novel is hardly reform. Instead it is deregulation, dressed as modernisation.

This Bill appears to be the backdoor version of the Gene Technology Bill that 97% of submitters opposed. Parliament should not allow industry capture to succeed through legislative sleight of hand.

We refer the committee particularly to the statements of social scientist Dr Jodie Bruning (personal here), and in her formal work for Physicians for Global Responsibility, who notes the main stakeholder served by the Bill is private industry. Also we commend the submission of JusticeWatchNZ, a legal advocacy group investigating elements of the covid response. It sets out the known unknowns of unleashing new organisms, and wonders why the bill addresses how to ease barriers to marketing risk-unknown biotechnologies when we should be asking why on earth would we?

This work has informed our thinking and this statement.

We urge the Committee to oppose this Bill.

Drs Cindy de Villiers, Alison Goodwin and Matt Shelton
On behalf of members and supporters

NZDSOS.com (New Zealand Doctors Speaking Out with Science)