The HSNO Amendment Bill: Faster Approvals Before Better Science?
Will the Legislative Amendments Frustrate the Purpose and Principles of the HSNO Act 1996 and Grease the Regulatory Wheels for GMO Release into the Environment?
PSGRNZ’s Submission (PDF) to the Primary Production Select Committee, Hazardous Substances and New Organisms Amendment Bill (304-1).
ALSO ON THIS TOPIC
PSGRNZ’s letter to the Parliamentary Commissioner for the Environment, Simon Upton.
RCR interview with PSGRNZ researcher J.R.Bruning.
The Hazardous Substances and New Organisms Amendment Bill (304-1) has been presented as a practical reform designed to make New Zealand’s regulatory system more efficient. The May 2025 Regulatory Impact Statement (RIS) claims that approval pathways for hazardous substances and new organisms are too slow, too complex, and too costly. The proposed solution is to streamline assessments, expand reliance on overseas regulators, reduce administrative burden, and create new approval pathways intended to accelerate innovation. Submissions close June 15, 2026.
Efficiency is a legitimate policy objective. No regulatory system should be unnecessarily cumbersome. However, the central question before Parliament is not whether efficiency is desirable.
The question is whether the mechanisms proposed in this Bill are compatible with the purpose and intent of the Hazardous Substances and New Organisms Act 1996.
The answer increasingly appears to be no.
The Bill arrives at a remarkable moment in New Zealand regulatory history. Last week the Ministry for the Environment was disestablished. In a month the CEO, Allan Freeth leaves the NZEPA. Then - at precisely the same time government papers have acknowledged that risk assessment models are outdated and no longer fit for purpose Parliament is being asked to expand the approvals that depend upon those same models. Rather than repairing the foundation before adding additional floors, the Government proposes to accelerate approvals while the underlying scientific architecture remains under review.
This reverses the order of regulatory reform.
If a risk assessment framework is acknowledged to be inadequate, the first priority should be to modernise that framework. Only once the methodology is transparent, robust, and capable of addressing contemporary scientific challenges should policymakers consider expanding approval pathways. Instead, the Bill largely assumes that these questions can be addressed later through regulations, guidance documents, administrative notices, and future policy development.
The approaches in the Ministry for the Environment’s Regulatory Impact Statement and in the content of the HSNO Amendment Bill creates a cascade of legal and scientific concerns.
A recurring phrase throughout the Regulatory Impact Statement is ‘risk-proportionate regulation’. The term is presented as self-evidently desirable. Yet the phrase itself has no established meaning within the HSNO Act 1996.
Before a regulator can determine whether a response is proportionate, it must first determine what risks exist, how uncertainty is characterised, what evidence has been considered, how conflicting findings are weighed, and what level of harm is considered acceptable. Without a transparent methodology, claims that regulation is risk-proportionate become assertions rather than demonstrable findings.
See comments on risk assessment being broken unfit by the Parliamentary Commissioner for the Environment and the Ministry for Regulation, while the NZEPA acknowledges models are out of date (NZEPA 2022 Methodology search ‘due course’).
PSGRNZ have discussed the impossibility of risk proportionate regulation when risk assessment doesn’t occur in our report discussing Gene Technology Reform.
Hazardous substances and new organisms are fundamentally different from many other regulatory domains. The risks associated with chemicals and self-replicating organisms are often delayed, cumulative, uncertain, difficult to reverse, and sometimes impossible to observe at the time a regulatory decision is made. Environmental persistence, endocrine disruption, mixture effects, ecosystem interactions, bioaccumulation, and long-term ecological consequences are precisely the kinds of issues that challenge conventional regulatory models.
In these circumstances, proportionality may require more scrutiny rather than less - and it deserves scrutiny that follows a transparent and accountable process.
The Parliamentary Commissioner for the Environment has repeatedly highlighted significant deficiencies in New Zealand’s approach to chemical governance (search ‘chemicals’). These concerns include inadequate information about chemicals in use, fragmented oversight systems, limited understanding of environmental fate, and insufficient tools for prioritising risks.
These concerns were directly relevant to the policy process that produced the current Bill.
Yet rather than beginning with those concerns, the underlying review process focused overwhelmingly on reducing delays, increasing efficiency, and improving access to products. Industry concerns about approval pathways became the organising principle around which reform was constructed. Questions relating to environmental health, public health, cumulative exposure, and scientific uncertainty became secondary considerations.
WHO WAS INVITED INTO THE ROOM?
The quality of legislation is heavily influenced by who is invited into the room when policy is being designed. The targeted consultation underpinning the Bill involved a small number of organisations, many of which had direct institutional interests in faster approvals. Missing from the process were many of the groups that traditionally provide countervailing perspectives: public health organisations, independent toxicologists, environmental NGOs, consumer representatives, and communities likely to bear the consequences of regulatory failure.
When consultation is dominated by organisations focused on obtaining approvals, the primary problem becomes how to move products through the system more quickly. Questions about whether the system is capable of identifying emerging risks receive far less attention.
As we discuss in section [1] of our submission, the RIS essentially drew it’s terms of reference - the problem and solution for the policy and HSNO Amendment Bill, directly from the Ministry of Regulation’s Agricultural and Horticultural Products Regulatory Review (February 2025).
The PCE pointed out that that Regulatory Review was narrowly targeted (page 14):
The Terms of Reference establish the industry as the primary stakeholder in this review. The review includes the formation of a specific industry sector reference group and a list of organisations which are invited to be part of this group. Though it mentions other stakeholder interests and indicates “targeted engagement with some selected stakeholders”, there is a lack of detail on who will be consulted, when, and how frequently. Regulations in respect of agricultural and animal products exist, in part, to provide some assurance that environmental and public health risks are being appropriately and transparently managed. Stakeholders representing these interests are just as important. As specialists in regulation, the Ministry will be well aware of the risks of regulatory capture by special interests. It is doubly important that a Ministry responsible for regulatory review avoids any such possibility.
The ‘Sector Reference Group’ for the Regulatory Review included the following:
The Sector Reference Group, who provided valuable insights and challenged our thinking on issues with the approval path and options for improvements. They include representatives from: Animal and Plant Health New Zealand, Dairy Companies Association New Zealand, Federated Farmers of New Zealand, Foundation for Arable Research, Horticulture New Zealand, Veterinary Council of New Zealand, and New Zealand Wine Growers.
The organisations that then took part in the targeted engagement for the HSNO Amendment Bill - were narrowly drawn from the industry sector, including the agrichemical lobby group formerly named AgCarm, and now titled Animal and Plant Health New Zealand (APHANZ). APHANZ was invited on the Regulatory Review ‘Sector Reference Group’ and to the Bill’s ‘targeted engagement’ which occurred in March 2025, one month after the Regulatory Review had been published.
This concern becomes particularly important when examining the Bill itself.
WAS THE RUSH TO ‘LOCK IT IN’ BEFORE THE NEW CEO ARRIVED?
The submission deadline of 15 June 2026 falls before the incoming EPA Chief Executive, Lian Butcher, takes office. While Ms Butcher has an environmental biology background, she lacks a background in chemicals regulation or the specialised regulatory interface at the core of the HSNO Act's operation.
The truncated submission window means that the Bill's architecture will be substantially fixed before the officer statutorily responsible for implementing it has had any opportunity to assess its implications, contribute technical EPA expertise to the select committee process, or exercise independent regulatory judgment. A new CEO arriving to a Bill already through select committee, with no expertise in regulatory systems, faced with a Bill with methodology requirements removed, public notification discretionary, and secondary legislation powers already delegated, inherits a framework she had no opportunity to scrutinise or contest.
AMBIGUOUS, DISCRETIONARY LANGUAGE
A striking feature of the legislation is the growing reliance on broad discretionary concepts rather than clearly defined statutory criteria. Terms such as ‘low risk’, ‘risk-proportionate’, ‘significant public interest’, ‘recognised international regulator’, ‘risk species’, ‘vagrant’, and even the newly invented term ‘denewed’ perform substantial regulatory work despite lacking clear legislative definition.
This represents a significant shift in regulatory philosophy.
One of the more unusual features of the Bill is the introduction of the term ‘denewed’. This seems to be an invented word. The concept appears designed to create a mechanism by which an organism that would otherwise fall within the scope of HSNO regulation may be administratively reclassified as not being a new organism. Once an organism is deemed no longer to be a new organism, it may move outside regulatory pathways specifically designed to manage uncertainty, containment, and oversight. This - plus complimentary tracts in the Bill, seem to enable officials to pretend that GMOs including gene edited organisms are not a GMO, directly contradicting the High Court finding Sustainability Council of New Zealand Trust v Environmental Protection Authority [2014] NZHC 1067. The court found that only Cabinet or Parliament, not the NZEPA, has the authority to determine which techniques are exempt from the GMO regime: the NZEPA had overstepped its powers by purporting to add gene-editing techniques to the exemption list administratively.
A term that performs such significant legal work should be accompanied by clear statutory criteria, evidential thresholds which are established following robust risk assessment processes, and safeguards. Instead, the concept appears largely dependent upon future administrative interpretation.
The Bill also places the ecological term ‘vagrant’ into a new regulatory category with legal consequences. In ecology, the term traditionally describes an organism occurring outside its normal range on a temporary or occasional basis. The Bill appears to transform this descriptive ecological concept into a gateway regulatory classification. The criteria determining when an organism becomes, remains, or ceases to be a vagrant is undefined. It could apply to genetically modified, gene-edited, volunteer, feral, or descendant organisms arising from escaped heritable material. In effect, a concept that appears scientific may function primarily as an administrative tool, with important regulatory consequences determined through discretion rather than transparent statutory criteria.
Together, ‘denewed’ and ‘vagrant’ illustrate the liminal foundations of the Bill: increasing reliance on novel administrative categories that perform substantial regulatory work while leaving much of their practical meaning to future interpretation by the regulator rather than Parliament.
BROAD, ENABLING POWERS
Historically, Parliament established key decision-making criteria within primary legislation. Under the proposed model, Parliament increasingly creates broad enabling powers while leaving substantive interpretation to future regulations, NZEPA notices, guidance documents, and administrative decisions.
The practical consequence is greater discretion and reduced certainty - just as the NZEPA step away from formal risk assessment and defer to foreign jurisdictions.
Supporters may argue that flexibility is necessary to accommodate scientific change. However, flexibility and accountability must move together. If decision-makers are granted broader discretion, there should be stronger requirements for transparency, evidence review, methodology publication, public participation, and independent scrutiny.
Without formal risk assessment, toxicological and epidemiological evaluations, without doing rigorous reviews, the agency scientists lack a deep understanding of what constitutes a rigorous evaluation and what can keep the environment and human health safe.
The increasing reliance on ambiguous and discretionary language cannot promote public trust. Legislation is intended to provide legal certainty, not merely broad policy direction. Where terms carry significant regulatory consequences, their meaning should be defined by Parliament rather than left to future interpretation through regulations, guidance, notices, or administrative practice. Otherwise, important policy decisions risk being made outside the legislative process and beyond meaningful parliamentary scrutiny.
A significant example concerns public participation. Under the current framework, public notification plays an important role in ensuring that affected communities, iwi, scientists, and health professionals can participate in decisions with potentially significant environmental and public health implications. The proposed amendments replace that presumption with a discretionary threshold based on whether the Authority considers there to be ‘significant public interest’.
This effectively transfers control over public participation to the regulator itself who then has the power to determine whether public participation is warranted. If it determines that participation is unnecessary, the public may never know an application existed. The implications of such a shift are profound.
Public participation is one of the mechanisms through which scientific uncertainty, local knowledge, cultural values, and overlooked risks enter decision-making processes. Removing participation does not remove uncertainty. It merely removes opportunities for uncertainty to be identified.
The same pattern appears in the Bill’s growing reliance on overseas regulatory decisions. International science and international regulatory cooperation have obvious value. New Zealand cannot realistically duplicate every assessment undertaken overseas. However, reliance on overseas decisions is only as reliable as the systems producing those decisions.
Two overseas approvals do not necessarily represent two independent scientific evaluations. Both decisions may ultimately rely upon the same underlying data, the same industry-sponsored studies, or the same originating assessment. Counting jurisdictions is not the same thing as evaluating evidence.
For example, the FAO-WHO JMPR may arrive at a decision, it might have arrived at a decision 10 years ago, using primarily industry supplied data. Australia may then make a decision based on the JMPR decision. In the meantime EFSA may have conducted a much more rigorous risk assessment, perhaps only in the last few years, but it might have resulted in tighter rules because a greater degree of risk and hence uncertainty over safety was highlighted. Nothing in the HSNO Act 1996 or in this Amendment Bill compels to NZEPA to select the highest quality and most recent assessment.
Yet the Bill increasingly treats overseas approval as a proxy for scientific confidence.
At a minimum, Parliament should ask whether the proposed framework contains sufficient mechanisms to assess the quality, currency, independence, and relevance of overseas assessments before they become the basis for New Zealand regulatory decisions.
PSGRNZ’s CALL TO MPS & THE SELECT COMMITTEE
PSGRNZ opposes this Bill and calls on members of Parliament to reject this Bill in its entirety. PSGRNZ request that the Primary Production Committee pause proceedings and return the Bill for fundamental revision, following genuine consultation extending well beyond the narrowly selected groups engaged to date.
Sections [4-7] of our Report and Submission highlights specific failings which PSGRNZ explicitly rejects.
PSGRNZ opposes the specific mechanisms this Bill uses to achieve efficiency, because they systematically reduce the scientific rigour, public participation, and independent oversight that the HSNO Act was designed to provide; and submit that the Regulatory Impact Statement (RIS) is unfit, and that the Bill is premature and fundamentally misconceived
THE REAL ISSUE AT HAND: PROTECTION OF HUMAN & ENVIRONMENTAL HEALTH
Ultimately, this debate is not about whether New Zealand should support innovation. It is about whether innovation should proceed ahead of the scientific and governance systems required to evaluate its risks.
The HSNO Act 1996 was established because Parliament recognised that hazardous substances and new organisms require special stewardship. The Act was designed not merely to facilitate approvals, but to manage uncertainty, protect public health, safeguard ecosystems, and ensure that decisions affecting future generations are made with appropriate caution.
The question before Parliament is therefore a constitutional one as much as a technical one.
If regulatory powers are being expanded, what safeguards are being strengthened at the same time?
If we defer to the decision of a foreign jurisdiction, how do we identify that that jurisdiction has
If public participation is reduced, what new accountability mechanisms replace it?
If scientific methodologies are removed from statute, where are the replacement evidential standards?
If Parliament intends to rely on overseas regulatory decisions, how will decision-makers establish that the originating jurisdiction applies scientific assessment processes, evidential standards, and regulatory safeguards of sufficient quality and robustness to meet New Zealand's statutory obligations under the HSNO Act and protect human health, the environment, and future generations?
If discretion is increased, what guarantees transparency?
Until those questions are answered, accelerating approvals is not regulatory modernisation. It is regulatory acceleration without corresponding scientific assurance.
Modernise the risk assessment framework first, establish transparent methodologies, ensure adequate regulatory capability, and only then consider whether approval pathways should be expanded through via amendments to the HSNO Act 1996.
Fix the foundation. Then build upon it.
TO KEEP READING: The Hazardous Substances and New Organisms Amendment Bill (304-1) (PSGRNZ’s Submission PDF)
