HNSO Act vs Gene Tech Bill
Up until 2025, all Gene Technology issues have fallen under the HNSO Act. Therefore in order to see what potential changes lay ahead, it is important to establish the differences between this Act and the Gene Technology Bill.
Here’s a clear, side-by-side comparison between the current HSNO Act (Hazardous Substances and New Organisms Act 1996) and the new Gene Technology Bill.
This shows exactly how the independence, precaution, and consultation processes change — and what that means for regulatory sovereignty and local safety.
🔹 Overview
| Purpose | HSNO Act 1996 | Gene Technology Bill (2024/2025) |
|---|---|---|
| Main focus | To protect people and the environment from the adverse effects of hazardous substances and new organisms (including genetically modified ones). | To regulate gene technology and related activities, aiming to “enable innovation” while managing risk. |
| Regulator | Environmental Protection Authority (EPA) | New Gene Technology Regulator (central authority under MBIE or MoH, depending on implementation). |
| Philosophy | Precautionary and independent: NZ must assess all GM or gene tech applications locally before approval. | Harmonised and fast-track oriented: NZ must follow decisions of two or more overseas “recognised authorities” for medical activities. |
🔹 1. Decision-making independence
| Element | HSNO Act | Gene Technology Bill |
|---|---|---|
| Local scientific assessment | Every new organism or genetically modified product must undergo a full NZ-based risk assessmentbefore approval (s. 38, s. 44). | If at least two overseas regulators have already authorised it, NZ must automatically approve it (s. 50). |
| Regulator discretion | The EPA may refuse approval if data is insufficient or if local conditions pose unique risks. | The Gene Tech Regulator cannot refuse, except in cases of “imminent risk” of death, injury, illness, or serious environmental harm. |
| Standard of proof | Uses the precautionary principle: lack of full scientific certainty is not a reason to approve. | Shifts to a reactive standard: must approve unless clear imminent danger exists. |
🔸 Effect: NZ loses its ability to “pause” approval pending local data or uncertainty. The burden of proof shifts from “prove it’s safe” to “prove it’s imminently unsafe.”
🔹 2. Public and iwi consultation
| Element | HSNO Act | Gene Technology Bill |
|---|---|---|
| Public submissions | Required for most GM applications (s. 53, s. 54). The EPA must publicly notify applications, accept written submissions, and may hold hearings. | The new Bill does not require public notification or consultation for “mandatory medical authorisations.” Decisions can be made administratively. |
| Māori consultation | The EPA must consider Treaty of Waitangi principles and consult where relevant (s. 6(d), s. 8). Māori impact assessment is standard practice. | The Bill mentions Treaty principles in general guiding provisions, but there is no mandatory iwi consultation for specific authorisations. |
| Transparency | Decisions, risk reports, and submissions are published on the EPA website. | Authorisations are classed as secondary legislation, so they’re published only after approval — public has no input beforehand. |
🔸 Effect: The public, iwi, and scientists in NZ may have no opportunity to question or contribute before foreign-approved gene technologies are authorised domestically.
🔹 3. Risk evaluation scope
| Element | HSNO Act | Gene Technology Bill |
|---|---|---|
| Environmental context | Must consider NZ’s “unique flora, fauna, and ecosystems” (s. 4A). | Only prevents approval if “serious environmental harm” is imminent — a much higher threshold. |
| Health and social factors | Must consider health, social, and ethical implications, including public acceptability (s. 4, s. 5). | Focused mainly on scientific and technical compliance; social or ethical review is not required. |
| Adaptive management | Allows conditions requiring ongoing monitoring, reporting, and review. | The Regulator may impose conditions, but there’s no requirement for ongoing public reporting. |
🔸 Effect: Environmental and social risk assessments become narrower and more reactive.
🔹 4. Sovereignty and international alignment
| Element | HSNO Act | Gene Technology Bill |
|---|---|---|
| Reference to overseas decisions | Overseas approvals may inform NZ assessments, but EPA remains independent. | Overseas approvals dictate NZ authorisation (mandatory). |
| Local override power | NZ can delay or deny any GMO or gene tech product based on local conditions. | NZ can only deny if there’s an imminent threat of serious harm — otherwise it must align. |
| Policy intent | “Protect New Zealand’s people and environment.” | “Enable the safe and responsible use of gene technology.” (shift toward enabling). |
🔸 Effect: Decision-making authority effectively shifts from Wellington to overseas regulators like the FDA or EMA.
🔹 5. Practical impact examples
| Scenario | Under HSNO Act | Under Gene Technology Bill |
|---|---|---|
| A new gene-edited wheat approved overseas | EPA conducts full NZ risk assessment (impact on native grasses, cross-pollination, biosecurity). | Regulator must approve if two overseas authorities did, unless imminent harm is proven. |
| A new mRNA vaccine or gene therapy approved overseas | Medsafe and EPA assess safety, storage, distribution, and NZ clinical trial data. | Regulator must authorise it once two overseas agencies have — no independent safety reassessment. |
| Public opposition or iwi concern | Public submissions and hearings possible; iwi consulted. | Decision made administratively; public informed after approval. |
🔹 6. In plain summary
| Area | HSNO Act (1996–2024) | Gene Technology Bill (2024+) |
|---|---|---|
| Decision basis | “Better safe than sorry.” | “If they approve, we approve.” |
| Public voice | Guaranteed. | Optional or absent. |
| Regulator’s discretion | Broad — can require new evidence, refuse, or delay. | Narrow — must approve unless imminent harm. |
| NZ sovereignty | Full control over GM and gene tech approvals. | Shared or ceded to overseas regulators. |
🧭 Overall meaning
The Gene Technology Bill fundamentally changes New Zealand’s biotechnology governance from an independent, precaution-based system to a harmonised, compliance-based system.
That means NZ:
Gains speed and access to overseas innovations,
But loses local authority to demand extra evidence, environmental testing, or public input before approval.